This document defines key terms related to software as a medical device (SaMD). It defines SaMD as software intended for medical purposes that performs those purposes without being part of a hardware medical device. SaMD is considered a medical device. The document also defines medical purpose, SaMD changes, the SaMD manufacturer, and intended use/purpose for SaMD. It is intended to provide a common framework for regulators in their oversight of SaMD.
Software as a Medical Device (SaMD) - IMDRF Definition and Categorisationpi
Following the growing importance of technology in healthcare, Medical Devices have begun to play an increasingly important role in the further development of the life sciences landscape.
One of its more remarkable and fastest growing segments goes under the name Software as a Medical Device. This presentation zooms in on the definition and categorisation, as used by the International Medical Device Regulators Forum.
The document discusses pharmaceutical regulations in Japan. It notes that Japan has the second largest pharmaceutical market behind the US. It also discusses regulations for clinical trials, marketing approval, and post-marketing safety measures. The key regulatory bodies are the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). Pharmaceutical companies must follow good manufacturing practice (GMP) standards and obtain various approvals to market and sell drugs in Japan.
Risk Based Classification of Medical Devices and groupingPaulyne Wairimu
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
drug registrastion requirements in china ...sonali mishraSonaliMishra64
The document discusses regulatory highlights and drug development in China. It provides an overview of the Chinese regulatory authority, currently called the National Medical Products Administration (NMPA), which oversees drug registration and clinical trials. It also summarizes the drug registration process in China, including requirements for imported drugs. This involves submitting clinical trial applications, conducting clinical trials, and obtaining an imported drug license. The document outlines categories for drug registration and review timelines, as well as opportunities for accelerated approval in China.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Software as a Medical Device (SaMD) - IMDRF Definition and Categorisationpi
Following the growing importance of technology in healthcare, Medical Devices have begun to play an increasingly important role in the further development of the life sciences landscape.
One of its more remarkable and fastest growing segments goes under the name Software as a Medical Device. This presentation zooms in on the definition and categorisation, as used by the International Medical Device Regulators Forum.
The document discusses pharmaceutical regulations in Japan. It notes that Japan has the second largest pharmaceutical market behind the US. It also discusses regulations for clinical trials, marketing approval, and post-marketing safety measures. The key regulatory bodies are the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). Pharmaceutical companies must follow good manufacturing practice (GMP) standards and obtain various approvals to market and sell drugs in Japan.
Risk Based Classification of Medical Devices and groupingPaulyne Wairimu
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
drug registrastion requirements in china ...sonali mishraSonaliMishra64
The document discusses regulatory highlights and drug development in China. It provides an overview of the Chinese regulatory authority, currently called the National Medical Products Administration (NMPA), which oversees drug registration and clinical trials. It also summarizes the drug registration process in China, including requirements for imported drugs. This involves submitting clinical trial applications, conducting clinical trials, and obtaining an imported drug license. The document outlines categories for drug registration and review timelines, as well as opportunities for accelerated approval in China.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
Content and format of dossier filling in india sandeep bansal
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Regulatory approval process for invitro diagnostics in usVinod Raj
This document summarizes the regulatory approval process for in vitro diagnostics (IVDs) in the United States. IVDs are classified into Class I, II, or III based on risk, with Class III devices requiring premarket approval. The main regulatory pathways for approval are 510(k) premarket notification for demonstrating substantial equivalence to a predicate device or the premarket approval (PMA) process for novel high-risk devices. Clinical Laboratory Improvement Amendments also provide quality standards for lab testing. The document reviews the classification system and options for 510(k), PMA, de novo, and lab developed tests.
The document discusses the regulation of medical devices in the United States. It begins by defining what constitutes a medical device according to the Code of Federal Regulations. It then outlines the key regulatory bodies that oversee medical devices, including the Center for Devices and Radiological Health and the Office of Combination Products. The document provides an overview of the classification system for medical devices and the different regulatory pathways for approval, including 510(k) premarket notification, investigational device exemptions, premarket approval, and humanitarian device exemption. It also summarizes the key requirements and processes for each approval pathway.
Post Marketing Requirements/Complaince: PMRs and PMCsDr. Reena Malik
This document discusses post-marketing requirements (PMRs) and post-marketing commitments (PMCs) required of drug sponsors after FDA approval. PMRs are studies required by regulation, while PMCs are studies agreed upon between the sponsor and FDA but not required. Sponsors must periodically report on the status of PMRs and PMCs, with certain details like enrollment required for clinical trials. The FDA provides guidance and websites for sponsors to report and check the status of post-marketing studies.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
International Medical Device Regulators ForumSanthiNori1
The document summarizes the International Medical Device Regulators Forum (IMDRF), which was established in 2011 to accelerate international harmonization of medical device regulations. It provides background on IMDRF's establishment and membership, which includes regulators from 11 countries and regions. The document also discusses IMDRF's relationship to the prior Global Harmonization Task Force (GHTF) and describes IMDRF's management structure, meetings, and current working groups on issues like adverse event terminology and medical device cybersecurity.
This document summarizes medical device regulations in the United States, European Union, and India. It discusses how medical devices are classified based on risk in each region, with Class I being lowest risk and Class III being highest. The regulatory approval processes for medical devices in each location are also outlined, including applying for certification marks like the FDA clearance in the US or CE Marking in the EU. Finally, the document provides statistics on the global market share of the medical device industry and references used.
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
This document discusses various FDA approval pathways for drugs, biologics, and medical devices. It describes the New Drug Application (NDA) process for drug approval, the Biologics License Application (BLA) process for biologics approval, the Premarket Approval (PMA) process for high-risk Class III medical devices, and the 510(k) process for clearance of lower-risk Class I and II medical devices. The key FDA regulations and goals of demonstrating safety and effectiveness for intended uses are also summarized.
This document summarizes a presentation given by Michael Swit on the 510(k) process for medical device clearance. The presentation covers the legal framework for 510(k) submissions, considerations for choosing device claims and introducing new features, evaluating device modifications that require new 510(k) filings, and the 510(k) review process. It provides guidance on strategies for obtaining 510(k) clearance, including starting with a narrow intended use and adding features incrementally, and the types of device changes that typically trigger a new 510(k).
The Commonwealth of Independent States (CIS) is an intergovernmental organization formed in 1991 by countries of the former Soviet Union. The document discusses pharmaceutical regulations and drug registration procedures in several CIS countries, including Russia, Ukraine, and Kazakhstan. Key aspects summarized include the regulatory authorities responsible for drug approval in each country, the typical registration process and requirements, and post-marketing pharmacovigilance obligations.
NSF certification, Standard for dietary supplementAtul Bhombe
NSF International is an independent organization that develops standards and certification programs to protect public health. They provide third-party certification to verify that products meet technical standards. NSF has developed Standard 173 for dietary supplements, which includes testing for contaminants and verifying label claims. The standard outlines requirements for raw materials, finished products, and labeling of dietary supplements. Manufacturers must submit information about product composition and testing methods to verify label claims under the standard.
Japan Medical Device Regulatory Approval ProcessKate Jablonski
Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, outlines some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
UDI consists of a unique device identifier (UDI) made up of a device identifier (DI) and production identifier(s) (PI). The DI is a static number assigned to each product model, while the PI contains variable information like serial number or lot number. UDI is displayed both visibly and in machine-readable form on medical devices and their packaging. Requiring UDI helps reduce medical errors, simplify data integration, and improve recall effectiveness. Exemptions may apply if direct marking could impact safety, performance, or additional processing is needed for single-use devices.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The document is a calendar showing months from January 2010 through January 2011. Each page displays a month's calendar with dates, days of the week and includes the month and year. The calendar is formatted in a grid with weeks running across pages to display full months consecutively.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
Content and format of dossier filling in india sandeep bansal
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Regulatory approval process for invitro diagnostics in usVinod Raj
This document summarizes the regulatory approval process for in vitro diagnostics (IVDs) in the United States. IVDs are classified into Class I, II, or III based on risk, with Class III devices requiring premarket approval. The main regulatory pathways for approval are 510(k) premarket notification for demonstrating substantial equivalence to a predicate device or the premarket approval (PMA) process for novel high-risk devices. Clinical Laboratory Improvement Amendments also provide quality standards for lab testing. The document reviews the classification system and options for 510(k), PMA, de novo, and lab developed tests.
The document discusses the regulation of medical devices in the United States. It begins by defining what constitutes a medical device according to the Code of Federal Regulations. It then outlines the key regulatory bodies that oversee medical devices, including the Center for Devices and Radiological Health and the Office of Combination Products. The document provides an overview of the classification system for medical devices and the different regulatory pathways for approval, including 510(k) premarket notification, investigational device exemptions, premarket approval, and humanitarian device exemption. It also summarizes the key requirements and processes for each approval pathway.
Post Marketing Requirements/Complaince: PMRs and PMCsDr. Reena Malik
This document discusses post-marketing requirements (PMRs) and post-marketing commitments (PMCs) required of drug sponsors after FDA approval. PMRs are studies required by regulation, while PMCs are studies agreed upon between the sponsor and FDA but not required. Sponsors must periodically report on the status of PMRs and PMCs, with certain details like enrollment required for clinical trials. The FDA provides guidance and websites for sponsors to report and check the status of post-marketing studies.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
International Medical Device Regulators ForumSanthiNori1
The document summarizes the International Medical Device Regulators Forum (IMDRF), which was established in 2011 to accelerate international harmonization of medical device regulations. It provides background on IMDRF's establishment and membership, which includes regulators from 11 countries and regions. The document also discusses IMDRF's relationship to the prior Global Harmonization Task Force (GHTF) and describes IMDRF's management structure, meetings, and current working groups on issues like adverse event terminology and medical device cybersecurity.
This document summarizes medical device regulations in the United States, European Union, and India. It discusses how medical devices are classified based on risk in each region, with Class I being lowest risk and Class III being highest. The regulatory approval processes for medical devices in each location are also outlined, including applying for certification marks like the FDA clearance in the US or CE Marking in the EU. Finally, the document provides statistics on the global market share of the medical device industry and references used.
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
This document discusses various FDA approval pathways for drugs, biologics, and medical devices. It describes the New Drug Application (NDA) process for drug approval, the Biologics License Application (BLA) process for biologics approval, the Premarket Approval (PMA) process for high-risk Class III medical devices, and the 510(k) process for clearance of lower-risk Class I and II medical devices. The key FDA regulations and goals of demonstrating safety and effectiveness for intended uses are also summarized.
This document summarizes a presentation given by Michael Swit on the 510(k) process for medical device clearance. The presentation covers the legal framework for 510(k) submissions, considerations for choosing device claims and introducing new features, evaluating device modifications that require new 510(k) filings, and the 510(k) review process. It provides guidance on strategies for obtaining 510(k) clearance, including starting with a narrow intended use and adding features incrementally, and the types of device changes that typically trigger a new 510(k).
The Commonwealth of Independent States (CIS) is an intergovernmental organization formed in 1991 by countries of the former Soviet Union. The document discusses pharmaceutical regulations and drug registration procedures in several CIS countries, including Russia, Ukraine, and Kazakhstan. Key aspects summarized include the regulatory authorities responsible for drug approval in each country, the typical registration process and requirements, and post-marketing pharmacovigilance obligations.
NSF certification, Standard for dietary supplementAtul Bhombe
NSF International is an independent organization that develops standards and certification programs to protect public health. They provide third-party certification to verify that products meet technical standards. NSF has developed Standard 173 for dietary supplements, which includes testing for contaminants and verifying label claims. The standard outlines requirements for raw materials, finished products, and labeling of dietary supplements. Manufacturers must submit information about product composition and testing methods to verify label claims under the standard.
Japan Medical Device Regulatory Approval ProcessKate Jablonski
Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, outlines some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
UDI consists of a unique device identifier (UDI) made up of a device identifier (DI) and production identifier(s) (PI). The DI is a static number assigned to each product model, while the PI contains variable information like serial number or lot number. UDI is displayed both visibly and in machine-readable form on medical devices and their packaging. Requiring UDI helps reduce medical errors, simplify data integration, and improve recall effectiveness. Exemptions may apply if direct marking could impact safety, performance, or additional processing is needed for single-use devices.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The document is a calendar showing months from January 2010 through January 2011. Each page displays a month's calendar with dates, days of the week and includes the month and year. The calendar is formatted in a grid with weeks running across pages to display full months consecutively.
This document provides instructions and learning objectives for a lesson on the novel A Long Walk to Water. Students are asked to self-reflect on their ability to cite evidence from the text and discuss challenges. They will then gather notes, participate in a discussion in small groups, and use their notes to write a pre-writing piece analyzing how culture, time and place influence the characters of Nya and Salva. Homework is to find an independent reading book to be approved by Friday.
This document provides learning objectives and instructions for students to read and analyze the article "Time Trip: Sudan's Civil War". It directs students to take out their homework, think about the differences between novels and news articles, and read the article to understand its main ideas. As they read, students are told to annotate the text and identify important vocabulary. They are then asked questions to analyze how the events in the article relate to the novel A Long Walk to Water and who the Lost Boys are.
What stakeholders really think of eLearning. Quality through self-evaluation.DeborahJane
SEVAQ+ is a tool and approach for self-evaluating the quality of technology-enhanced learning. It allows users to create questionnaires based on recognized quality frameworks, analyze results from different stakeholders, and improve courses. The project aims to support quality and attractiveness of vocational and higher education. SEVAQ+ extends an earlier version to include additional stakeholders like managers and trainers, contexts like vocational and higher education, and frameworks like EFQM and Kirkpatrick models. It was tested by over 1500 current testers across Europe to validate the tool.
Team Up with Families: Using Technology to Build BridgesJennifer Orr
Jennifer Orr is interested in engaging with families to support their children's education by working as a team for students. She suggests making communication easy by using tools that don't require logging in and centralizing information as much as possible, such as through a class blog.
Este documento es una carta de un padre dirigida a sus hijas. Les dice que siempre guarden su corazón puro y nunca se alejen de Dios, ya que descienden de lo santo y estarán siempre en su corazón. Les expresa su amor más profundo como padre.
Support & Help for Academic Researchers by using Information Technology (SHA...Martin Rehm
The present paper will investigate how web 2.0 tools can contribute to the goal
of sharing (tacit) knowledge amongst young researchers from different disciplines, and
investigate the factors influencing the take-up of such tools. To this end, we will first
describe how a Dutch university has addressed this issue by means of a blog that is
developed to provide support and help for academic researchers by using information
technology (SHARE-IT). Next to providing an overview of the initiative, we will
describe how young researchers’ perceptions and attitudes of such blogs can be assessed.
Based on the seminal model on unified theory of acceptance and use of technology
(UTAUT) (Venkatesh, Morris, Gordon, & Davis, 2003), we will develop a questionnaire
that aims at determining young researchers’ web 2.0 behavior. Additionally, a second
questionnaire will be distributed, measuring factors that support or inhibit individuals’
knowledge sharing intentions (Bock, Zmund, Kim, & Lee, 2005). By contrasting the
findings with the results of similar research in the UK (Procter, Williams, & Stewart,
2010), we will then be able to provide valuable insights on the way young researchers,
across countries, approach and perceive blogs and other web 2.0 technologies.
Slides to support a workshop at a University of Suffolk teaching and learning day on 14 December 2016. The workshop looked at challenges involved in sourcing digital resources for learning and teaching, and discussed the role that OER might play. We also looked briefly at the Jisc resource and app store, in beta at December 2016.
The document proposes an enhanced and interactive ebook platform that would allow textbook publishers and content creators to add multimedia, tests, quizzes and other ancillary materials to textbooks, addressing different learning styles. The platform would provide these enhanced ebooks through applications on various devices and generate higher margins for content creators. It seeks funding to expand its services and software, hire a Chief Creative Officer, and target small and medium publishers and professional organizations as its niche.
This document provides advice for creating and delivering an effective presentation. It emphasizes having a clear objective that results in action from the audience. The content should be short, simple, and strongly connected. Presentations should follow brain rules by incorporating visuals, storytelling structure, and engaging the emotions of the audience. The presenter is also important and should avoid being boring by having a purpose, engaging the audience, and ending with a call to action.
This presentation was given at the Western New York Paralegal Association on February 18, 2010. It's a more traditional powerpoint than I like to give (lots of bullet points and text) because it was intended for distribution to non-attendees as well as attendees.
The presentation was a primer for paralegals on the topics of litigation holds, preservation, records management and the challenges social media present for all of these areas.
Enjoy!
Presenting malta etwinning project (dorianne agius)Gavranica
This document provides information about San Gorg Preca College in Malta. It discusses the climate and population of Malta. It then describes details about the town of Paola, Malta, where the school is located, including its motto, coat of arms, and places of interest. It introduces San Gorg Preca College, named after a Maltese saint, and provides details about the schools it incorporates. It concludes with information about Paola Primary A, the specific school being discussed, including its location, classes, coat of arms, annex location, environmental programs, and a seasonal greeting from the students.
Occupabilità e competitività come muoversi da protagonista nel mondo che cambia.Carlo Colomba
Sono le persone a subire le conseguenze della crisi economica in atto. Ma i veri
processi di cambiamento non possono prescindere dall’impegno e dalla
responsabilità personali. Rispetto ai coetanei di altri Paesi i nostri giovani incontrano il lavoro in età troppo avanzata e, per di più, con conoscenze poco spendibili anche per l’assenza di un vero contatto con il mondo del lavoro in ragione del noto pregiudizio che vuole che chi studia non lavori e che chi lavora non studi. Una promozione della cultura del lavoro e dell’organizzazione aziendale porterebbe benefici sia per i lavoratori che per le imprese, ma l’Italia rimane agli ultimi posti in Europa per quanto riguarda la
partecipazione della popolazione ad attività di formazione continua e per l’alternanza scuola/lavoro. Si tratta di promuovere una cultura dell’apprendimento permanente tra i giovani e gli adulti rimodellando tempi, contenuti e modalità di coinvolgimento all’interno di un sistema di certificazione dei saperi e delle competenze possedute funzionale ad un reale aumento dell’occupabilità a supporto dei momenti di transizione nella vita e nel lavoro.
projekt, który wysłaliśmy na konkurs pt. Urban legends. publikujemy go w takiej formie dnia 26.03.2009 ze względu na często zdarzające się kradzieże pomysłów i projektów.
Switzerland is a mountainous country located in Central Europe known for its scenic landscape, lakes, and ski resorts. Some of its major cities include Geneva, Lucerne, and Zurich which feature historic architecture and attractions like CERN. The country is also popular for winter sports in the Alps with towns like Davos and Engelberg located near snow-capped peaks.
EU regulatory frameworks - Legal challenges and opportunities for digital hea...DayOne
Presentation by Karin Schulze, Head of Medical Devices at SFL at the DayOne Expert Event Legal challenges and opportunities for digital health innovation
Regulation
Regarding the new MDR, the big question that arises is not only whether a piece of software falls under the definition of a medical device, but also who decides whether it does. At least in this regard the new regulation is clear: it is the regulator. Which means, according to Karin Shulze from SFL, that If a company offers an app which they do not consider a medical device themselves, but the regulator does, the distribution of this app will be stopped.
The regulation of software: Medicines, biologicals, blood, tissues and devicesTGA Australia
This presentation is an overview of the software regulated by the TGA, a brief introduction to the International Medical Device Regulators' Forum's Software as a Medical Device project and details of how the TGA takes a systems approach to the regulation of software.
Update on software as a medical device (SaMD)TGA Australia
This presentation will explore the definition of a medical device and how this applies to software. In addition, the nuances of the kinds of software will be discussed in relation to their likely classification as a medical device.
Review Mdcg 2019-11 guidance on qualification and classification of software Antonio Bartolozzi
This document provides guidance on classifying software as a medical device under the EU Medical Device Regulation and In Vitro Diagnostic Regulation. It discusses definitions of key terms like "software" and "medical device software" and outlines classification rules. Specifically, Rule 11 provides guidance on classifying software based on its intended purpose and potential risks. However, the document notes some issues, uncertainties and potential inconsistencies with how software is classified compared to hardware medical devices under Rule 11 and Article 51 of the regulations. It raises questions about how to appropriately define and qualify standalone software as a medical device to ensure a risk-based and legally compliant classification approach.
SaMD or Software as a Medical Device can be described as a software constructed to be used in medical devices. These softwares can be run on different operating systems and virtual platforms.
1. The basic programming model of a SaMD is given below.
2. Different softwares are used for medical purposes, and they include the following:
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EU Medical Device Directive Newcastle MayHANDI HEALTH
HANDIHealth is developing apps to transform healthcare using an app-based model. The presentation discusses how the European Medical Device Directive (MDD) may apply to medical apps. It notes that apps influencing clinical decisions or therapy should be considered medical devices. Key requirements for medical devices include clinical safety risk analysis, quality management systems, and post-market surveillance. The intended use and ability to analyze data to generate new information help determine if software meets the definition of a medical device. Manufacturers of apps deemed medical devices must comply with the MDD.
Regulation of software as medical devicesTGA Australia
Software can be regulated as a medical device if it meets the definition under Australian law. The intended purpose of the software must be for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury. Regulators are working to clarify how quality management system principles apply to software. Post-market, issues can include software crossing regulatory lines over multiple upgrades and not properly reporting safety incidents.
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...TGA Australia
The document summarizes the results of a consultation on proposed reforms to the regulation of software as a medical device in Australia. It discusses key points from international approaches to classifying and regulating software, proposed new classification rules and essential principles for software in Australia, and the results of the consultation which found general agreement with the proposals among respondents.
Update on software as a medical device (SaMD)TGA Australia
This presentation explores the definition of a medical device and how this applies to software. In addition, the nuances of the kinds of software are discussed in relation to their likely classification as a medical device.
The document discusses the evolution and goals of the Unique Device Identification (UDI) system, which aims to uniquely identify medical devices and their attributes to improve safety. It outlines the roles of regulatory bodies like the FDA and IMDRF in developing UDI requirements. The UDI system is expected to benefit stakeholders by improving traceability, reducing errors, and enabling efficient recalls. However, implementing UDI presents challenges for medical device manufacturers related to integrating it into organizational processes and systems. Outsourcing partners with expertise in medical device engineering can help manufacturers implement UDI more quickly and cost-effectively.
Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. September 25, 2013
http://www.alfonsogadea.es/apps-salud-poniendo-orden/
The FDA issued guidance on mobile medical applications to clarify which apps it intends to regulate. Many mobile apps are not medical devices and are not regulated by the FDA. Some apps may meet the definition of a medical device but pose low risks, so the FDA will exercise enforcement discretion over them. The FDA intends to regulate only mobile medical apps that are medical devices and whose malfunction could endanger patient safety. The guidance aims to provide clarity and predictability for manufacturers of mobile medical apps.
Design Controls for Medical Device Data SystemsEMMAIntl
Medical Device Data Systems (MDDS) are hardware or software products that are intended to transfer, store, convert document forms and display medical device data. MDDS on its own does not modify the data or control any functions of the connected medical device and may or may not be used in active patient monitoring...
Medical technologies and data protection issues - food for thoughtRenato Monteiro
Document prepared towards the modernization procedure of Council of Europe´s Convention 108 on the Protection of Personal Data. Available at: http://www.coe.int/t/dghl/standardsetting/dataprotection/TPD_documents/T-PD-BUR%282014%2904Rev%20-%20Medical%20Data%20%28By%20Renato%20Leite%29.pdf
Medical technologies and data protection issues - food for thoughtRenato Monteiro
Document prepared towards the modernization procedure of Council of Europe´s Convention 108 on the Protection of Personal Data. Available at: http://www.coe.int/t/dghl/standardsetting/dataprotection/TPD_documents/T-PD-BUR%282014%2904Rev%20-%20Medical%20Data%20%28By%20Renato%20Leite%29.pdf
This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.
Similar to Imdrf tech-131209-samd-key-definitions-140901 (20)
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTblessyjannu21
Prepared by Prof. BLESSY THOMAS, VICE PRINCIPAL, FNCON, SPN.
Emphysema is a disease condition of respiratory system.
Emphysema is an abnormal permanent enlargement of the air spaces distal to terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
Emphysema of lung is defined as hyper inflation of the lung ais spaces due to obstruction of non respiratory bronchioles as due to loss of elasticity of alveoli.
It is a type of chronic obstructive
pulmonary disease.
It is a progressive disease of lungs.
At Malayali Kerala Spa Ajman, Full Service includes individualized care for every client. We specifically design each massage session for the individual needs of the client. Our therapists are always willing to adjust the treatments based on the client's instruction and feedback. This guarantees that every client receives the treatment they expect.
By offering a variety of massage services, our Ajman Spa Massage Center can tackle physical, mental, and emotional illnesses. In addition, efficient identification of specific health conditions and designing treatment plans accordingly can significantly enhance the quality of massaging.
At Malayali Kerala Spa Ajman, we firmly believe that everyone should have the option to experience top-quality massage services regularly. To achieve that goal we offer cheap massage services in Ajman.
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Sectional dentures for microstomia patients.pptxSatvikaPrasad
Microstomia, characterized by an abnormally small oral aperture, presents significant challenges in prosthodontic treatment, including limited access for examination, difficulties in impression making, and challenges with prosthesis insertion and removal. To manage these issues, customized impression techniques using sectional trays and elastomeric materials are employed. Prostheses may be designed in segments or with flexible materials to facilitate handling. Minimally invasive procedures and the use of digital technologies can enhance patient comfort. Education and training for patients on prosthesis care and maintenance are crucial for compliance. Regular follow-up and a multidisciplinary approach, involving collaboration with other specialists, ensure comprehensive care and improved quality of life for microstomia patients.
Ensure the highest quality care for your patients with Cardiac Registry Support's cancer registry services. We support accreditation efforts and quality improvement initiatives, allowing you to benchmark performance and demonstrate adherence to best practices. Confidence starts with data. Partner with Cardiac Registry Support. For more details visit https://cardiacregistrysupport.com/cancer-registry-services/
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"Market Research it too text-booky, I am in the market for a decade, I am living research book" this is what the founder I met on the event claimed, few of my colleagues rolled their eyes. Its true that one cannot over look the real life experience, but one cannot out beat structured gold mine of market research.
Many 0 to 1 startup founders often overlook market research, but this critical step can make or break a venture, especially in health tech.
But Why do they skip it?
Limited resources—time, money, and manpower—are common culprits.
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Sudharsan Srinivasan
Operational Partner Pitchworks VC Studio
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Example of Market Research working
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Identifying Pain Points: Innovaccer surveyed healthcare providers to understand their difficulties with data integration, care coordination, and patient engagement. They found widespread frustration with siloed systems and inefficient workflows.
Competitive Analysis: Analyzed competitors offering similar solutions in healthcare analytics and interoperability. Identified gaps in comprehensive data aggregation, real-time analytics, and actionable insights.
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As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
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THE SPECIAL SENCES- Unlocking the Wonders of the Special Senses: Sight, Sound...Nursing Mastery
Title: Unlocking the Wonders of the Special Senses: Sight, Sound, Smell, Taste, and Balance
Introduction:
Welcome to our captivating SlideShare presentation on the Special Senses, where we delve into the extraordinary capabilities that allow us to perceive and interact with the world around us. Join us on a sensory journey as we explore the intricate structures and functions of sight, sound, smell, taste, and balance.
The special senses are our primary means of experiencing and interpreting the environment, each sense providing unique and vital information that shapes our perceptions and responses. These senses are facilitated by highly specialized organs and complex neural pathways, enabling us to see a vibrant sunset, hear a symphony, savor a delicious meal, detect a fragrant flower, and maintain our equilibrium.
In this presentation, we will:
Visual System (Sight): Dive into the anatomy and physiology of the eye, exploring how light is converted into electrical signals and processed by the brain to create the images we see. Understand common vision disorders and the mechanisms behind corrective measures like glasses and contact lenses.
Auditory System (Hearing): Examine the structures of the ear and the process of sound wave transduction, from the outer ear to the cochlea and auditory nerve. Learn about hearing loss, auditory processing, and the advances in hearing aid technology.
Olfactory System (Smell): Discover the olfactory receptors and pathways that enable the detection of thousands of different odors. Explore the connection between smell and memory and the impact of olfactory disorders on quality of life.
Gustatory System (Taste): Uncover the taste buds and the five basic tastes – sweet, salty, sour, bitter, and umami. Delve into the interplay between taste and smell and the factors influencing our food preferences and eating habits.
Vestibular System (Balance): Investigate the inner ear structures responsible for balance and spatial orientation. Understand how the vestibular system helps maintain posture and coordination, and explore common vestibular disorders and their effects.
Through engaging visuals, interactive diagrams, and insightful explanations, we aim to illuminate the complexities of the special senses and their profound impact on our daily lives. Whether you're a student, educator, or simply curious about how we perceive the world, this presentation will provide valuable insights into the remarkable capabilities of the human sensory system.
Join us as we unlock the wonders of the special senses and gain a deeper appreciation for the intricate mechanisms that allow us to experience the richness of our environment.
Digital Health in India_Health Informatics Trained Manpower _DrDevTaneja_15.0...DrDevTaneja1
Digital India will need a big trained army of Health Informatics educated & trained manpower in India.
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We look into the evolution of health informatics and its applications in the healthcare industry.
HIMMS TIGER resources are available to assist Health Informatics education.
Indian Health universities, IT Education institutions, and the healthcare industry must proactively collaborate to start health informatics courses on a big scale. An advocacy push from various stakeholders is also needed for this goal.
Health informatics has huge employment potential and provides a big business opportunity for the healthcare industry. A big pool of trained health informatics manpower can lead to product & service innovations on a global scale in India.
Test bank advanced health assessment and differential diagnosis essentials fo...rightmanforbloodline
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nursing management of patient with Empyema pptblessyjannu21
prepared by Prof. BLESSY THOMAS, SPN
Empyema is a disease of respiratory system It is defines as the accumulation of thick, purulent fluid within the pleural space, often with fibrin development.
Empyema is also called pyothorax or purulent pleuritis.
It’s a condition in which pus gathers in the area between the lungs and the inner surface of the chest wall. This area is known as the pleural space.
Pus is a fluid that’s filled with immune cells, dead cells, and bacteria.
Pus in the pleural space can’t be coughed out. Instead, it needs to be drained by a needle or surgery.
Empyema usually develops after pneumonia, which is an infection of the lung tissue. it is mainly caused due in infectious micro-organisms. It can be treated with medications and other measures.
2. IMDRF/SaMD WG/N10FINAL:2013
_______________________________________________________________________________________
Table of Contents
1.0 Introduction......................................................................................................................4
2.0 Scope ...............................................................................................................................5
3.0 References........................................................................................................................5
4.0 Definitions........................................................................................................................5
5.0 Key Definitions ................................................................................................................6
5.1 Software as a Medical Device .......................................................................................6
5.2 Medical purpose............................................................................................................6
5.2.1 Medical Device......................................................................................................6
5.2.2 In Vitro Diagnostic (IVD) medical device..............................................................7
5.2.3 Additional considerations for SaMD ......................................................................7
5.3 SaMD Changes .............................................................................................................8
5.4 SaMD Manufacturer .....................................................................................................8
5.5 Intended use / intended purpose ....................................................................................9
5.5.1 Additional considerations for SaMD ......................................................................9
9 December 2013 Page 2 of 9
3. IMDRF/SaMD WG/N10FINAL:2013
_______________________________________________________________________________________
Preface
The document herein was produced by the International Medical Device Regulators Forum
(IMDRF), a voluntary group of medical device regulators from around the world. The document
has been subject to consultation throughout its development.
There are no restrictions on the reproduction, distribution or use of this document; however,
incorporation of this document, in part or in whole, into any other document, or its translation
into languages other than English, does not convey or represent an endorsement of any kind by
the International Medical Device Regulators Forum.
9 December 2013 Page 3 of 9
4. IMDRF/SaMD WG/N10FINAL:2013
_______________________________________________________________________________________
1.0 Introduction
Software is becoming increasingly important and pervasive in healthcare. Given the availability
of a multitude of technology platforms (e.g., personal computers, smart phones, network servers,
etc.), as well as increasing ease of access and distribution (e.g., internet, cloud), software created
for medical purposes (software used to make clinical decisions) and non-medical purpose (e.g.,
administrative, financial) are being used in healthcare.
In general, existing regulations address public health risks of software when embedded in a
traditional medical device. However, the current application of regulations and controls may not
always translate or address the unique public health risks posed by Software as a Medical Device
(SaMD) nor assure an appropriate balance between patient/consumer protection and promotion
of public health by facilitating innovation.
This is the first of a collection of documents that will be developed by the International Medical
Device Regulators Forum (IMDRF) to establish a common framework for regulators to
incorporate converged controls into their regulatory approaches for SaMD..
This collection of IMDRF SaMD documents will provide regulators with the fundamental
building blocks and a common understanding of the many kinds and importance of software for
medical purposes in advancing public health. Generally medical purpose software1
consists of:
(1) software in a medical device (sometimes referred to as “embedded” or “part of”);
(2) software as a medical device (SaMD).
This document IMDRF SaMD WG N10/Software as a Medical Device2
: Key Definitions focuses
on a common definition for when software is considered to be a medical device and a reminder
of other key terms, some previously defined in Global Harmonization Task Force (GHTF)
documents, with relevance to SaMD. The key definitions and terms developed in IMDRF SaMD
WG N10 will be used to develop future documents that provide a common framework for
identifying types of SaMD and associated risks and controls to minimize these risks.
Some regulators have taken individual approaches to assure safety, effectiveness, and
performance of SaMD. Such approaches have common public health goals. The objective of this
effort is to promote consistent expectations for SaMD and to provide an optimal level of patient
safety while fostering innovation and ensuring patients and providers have continued access to
advances in healthcare technology.
1
Software used to make or maintain a device (testing, source code management, servicing, etc.) is not considered
software with a medical purpose.
2
This IMDRF document converges on the term SaMD to replace the term “standalone software” or “standalone
medical device software”. However the concepts of standalone software are included in this converged definition
of SaMD.
9 December 2013 Page 4 of 9
5. IMDRF/SaMD WG/N10FINAL:2013
_______________________________________________________________________________________
2.0 Scope
This document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses
on a common definition for when software is considered to be a medical device and a reminder
of other key terms, some previously defined in Global Harmonization Task Force (GHTF)
documents, with relevance to SaMD.
Software intended as an accessory to a medical device is not in the scope of this document,
unless the software meets the definition of SaMD in this document.
This document focuses on the definition of the SaMD irrespective of software technology and/or
platform (e.g., mobile app, cloud).
3.0 References
• GHTF/SG1/N55:2008 Definition of the Terms Manufacturer, Authorised Representative,
Distributor and Importer
• GHTF/SG1/N70:2011 Label and Instructions for Use for Medical Devices
• GHTF/SG1/N71:2012 Definition of Terms Medical Device and In Vitro Diagnostic
Medical Device
• ISO/IEC 14764:2006 Software Engineering — Software Life Cycle Processes —
Maintenance
4.0 Definitions
This section is intentionally left blank as the definitions are contained within the body of this
document.
9 December 2013 Page 5 of 9
6. IMDRF/SaMD WG/N10FINAL:2013
_______________________________________________________________________________________
5.0 Key Definitions
5.1 Software as a Medical Device
The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for
one or more medical purposes that perform these purposes without being part of a hardware
medical device.
NOTES:
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.
• SaMD is capable of running on general purpose (non-medical purpose) computing platforms3
• “without being part of” means software not necessary for a hardware medical device to
achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical
device.
• SaMD may be used in combination (e.g., as a module) with other products including medical
devices;
• SaMD may be interfaced with other medical devices, including hardware medical devices and
other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD.
5.2 Medical purpose
The following two terms as defined in GHTF/SG1/N71:2012 (italicized below) identify medical
purpose applicable to SaMD:
5.2.1 Medical Device
‘Medical device’ means any instrument, apparatus, implement, machine, appliance,
implant, reagent for in vitro use, software, material or other similar or related article, intended
by the manufacturer to be used, alone or in combination, for human beings, for one or more of
the specific medical purpose(s) of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a
physiological process,
• supporting or sustaining life,
• control of conception,
3
“Computing platforms” include hardware and software resources (e.g. operating system, processing hardware,
storage, software libraries, displays, input devices, programming languages etc.).
“Operating systems” that SaMD require may be run on a server, a workstation, a mobile platform, or other general
purpose hardware platform.
9 December 2013 Page 6 of 9
7. IMDRF/SaMD WG/N10FINAL:2013
_______________________________________________________________________________________
• disinfection of medical devices,
• providing information by means of in vitro examination of specimens derived from
the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means.
Note: Products which may be considered to be medical devices in some jurisdictions but
not in others include:
• disinfection substances,
• aids for persons with disabilities,
• devices incorporating animal and/or human tissues,
• devices for.in-vitro fertilization or assisted reproduction technologies.
5.2.2 In Vitro Diagnostic (IVD) medical device
‘In Vitro Diagnostic (IVD) medical device’ means a medical device, whether used alone
or in combination, intended by the manufacturer for the in-vitro examination of specimens
derived from the human body solely or principally to provide information for diagnostic,
monitoring or compatibility purposes.
Note 1: IVD medical devices include reagents, calibrators, control materials, specimen
receptacles, software, and related instruments or apparatus or other articles and are used,
for example, for the following test purposes: diagnosis, aid to diagnosis, screening,
monitoring, predisposition, prognosis, prediction, determination of physiological status.
Note2: In some jurisdictions, certain IVD medical devices may be covered by other
regulations.
5.2.3 Additional considerations for SaMD
SaMD may also:
• provide means and suggestions for mitigation of a disease;
• provide information for determining compatibility, detecting, diagnosing, monitoring
or treating physiological conditions, states of health, illnesses or congenital
deformities;
• be an aid to diagnosis, screening, monitoring, determination of predisposition;
prognosis, prediction, determination of physiological status.
9 December 2013 Page 7 of 9
8. IMDRF/SaMD WG/N10FINAL:2013
_______________________________________________________________________________________
5.3 SaMD Changes
SaMD Changes refer to any modifications made throughout the lifecycle of the SaMD including
the maintenance phase.
Software maintenance4
can include adaptive (e.g. keeps pace with the changing environment),
perfective (e.g. recoding to improve software performance), corrective (e.g. corrects discovered
problems), or preventive (e.g. corrects latent faults in the software product before they become
operational faults).
Examples of SaMD changes include, but are not limited to, defect fixes; aesthetic, performance
or usability enhancements; and security patches.
5.4 SaMD Manufacturer
For SaMD manufacturer the definition in GHTF/SG1/N55:2009 applies:
“Manufacturer” means any natural or legal person5
with responsibility for design and/or
manufacture of a medical device with the intention of making the medical device available for
use, under his name; whether or not such a medical device is designed and/or manufactured by
that person himself or on his behalf by another person(s).
NOTES:
1. This ‘natural or legal person’ has ultimate legal responsibility for ensuring
compliance with all applicable regulatory requirements for the medical device in the
countries or jurisdictions where it is intended to be made available or sold, unless
this responsibility is specifically imposed on another person by the Regulatory
Authority (RA) within that jurisdiction.
2. The manufacturer’s responsibilities are described in other GHTF guidance
documents. These responsibilities include meeting both pre-market requirements
4
ISO/IEC 14764:2006 Software Engineering — Software Life Cycle Processes — Maintenance
• adaptive maintenance: the modification of a software product, performed after delivery, to keep a
software product usable in a changed or changing environment.
• perfective maintenance: the modification of a software product after delivery to detect and correct latent
faults in the software product before they are manifested as failures
• corrective maintenance: the reactive modification of a software product performed after delivery to
correct discovered problems
• preventive maintenance: the modification of a software product after delivery to detect and correct
latent faults in the software product before they become operational faults
5
The term “person” that appears here and in the other definitions of this document, includes legal entities such as a
corporation, a partnership or an association.
9 December 2013 Page 8 of 9
9. IMDRF/SaMD WG/N10FINAL:2013
_______________________________________________________________________________________
and post-market requirements, such as adverse event reporting and notification of
corrective actions.
3. ‘Design and/or manufacture’, as referred to in the above definition, may include
specification development, production, fabrication, assembly, processing, packaging,
repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of
a medical device; or putting a collection of devices, and possibly other products,
together for a medical purpose.
4. Any person who assembles or adapts a medical device that has already been
supplied by another person for an individual patient, in accordance with the
instructions for use, is not the manufacturer, provided the assembly or adaptation
does not change the intended use of the medical device.
5. Any person who changes the intended use of, or modifies, a medical device without
acting on behalf of the original manufacturer and who makes it available for use
under his own name, should be considered the manufacturer of the modified medical
device.
6. An authorised representative, distributor or importer who only adds its own address
and contact details to the medical device or the packaging, without covering or
changing the existing labelling, is not considered a manufacturer.
7. To the extent that an accessory is subject to the regulatory requirements of a medical
device6
, the person responsible for the design and/or manufacture of that accessory
is considered to be a manufacturer.
5.5 Intended use / intended purpose
For SaMD intended use, the definition in GHTF/SG1/N70:2011 “Label and Instructions for Use
for Medical Devices” applies:
The term “intended use / intended purpose” is the objective intent of the manufacturer regarding
the use of a product, process or service as reflected in the specifications, instructions and
information provided by the manufacturer.
5.5.1 Additional considerations for SaMD
Although not specifically included in the GHTF definition materials such as sales and
marketing materials may be considered as “information provided by the manufacturer”
and therefore reflect the objective intent of the manufacturer. Sales and marketing
materials should be comprehensive and reflect the intended use of the SaMD.
6
See GHTF/SG1/N29 Information Document Concerning the Definition of the Term “Medical Device”
9 December 2013 Page 9 of 9