1. The document discusses the classification of medical device software under the EU Medical Device Regulation (MDR) Rules 11 and 10.
2. Rule 11 classifies software intended for diagnosis or therapeutic purposes as Class IIa, except if the impact could cause death, irreversible health deterioration, or serious health deterioration, in which case it is Class III or IIb respectively.
3. The document argues that Rules 10 and 11 define different classifications for devices intended for the same use (diagnosis), depending on whether the device has software, creating inconsistencies.
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.
Clinical investigations - Intended Normal condition of use Antonio Bartolozzi
Clinical investigations of medical devices shall be performed:
1) By a sufficient number of intended users in a clinical environment representative of how the device will normally be used by the target patient population.
2) In accordance with the clinical investigation plan and clinical evaluation plan.
3) Under conditions of intended normal use, which includes foreseeable errors and misuse during intended operation according to the manufacturer's instructions.
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.
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.
1. The document discusses the classification of medical device software under the EU Medical Device Regulation (MDR) Rules 11 and 10.
2. Rule 11 classifies software intended for diagnosis or therapeutic purposes as Class IIa, except if the impact could cause death, irreversible health deterioration, or serious health deterioration, in which case it is Class III or IIb respectively.
3. The document argues that Rules 10 and 11 define different classifications for devices intended for the same use (diagnosis), depending on whether the device has software, creating inconsistencies.
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.
Clinical investigations - Intended Normal condition of use Antonio Bartolozzi
Clinical investigations of medical devices shall be performed:
1) By a sufficient number of intended users in a clinical environment representative of how the device will normally be used by the target patient population.
2) In accordance with the clinical investigation plan and clinical evaluation plan.
3) Under conditions of intended normal use, which includes foreseeable errors and misuse during intended operation according to the manufacturer's instructions.
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.
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.
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.
Mobile Medical Apps and FDA Regulatory ApproachAkshay Anand
A presentation on Food Safety and Standards Authority of India. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015
This document summarizes key aspects of legal and regulatory issues related to medical device software in the European Union. It discusses when software is considered a medical device and must be CE marked. It also outlines manufacturer obligations, classification rules, standards and guidance, clinical evaluation requirements, and emerging issues around networked devices and eHealth.
This document discusses when a mobile app would be considered a medical device and require CE marking under the European Medical Devices Directive. An app is a medical device if it is intended by its manufacturer to be used for medical purposes like diagnosis, treatment or monitoring of disease. Standalone medical software or software incorporated into a medical device would require CE marking. The document outlines the classification process for medical devices and implications of CE marking, including meeting essential safety requirements and allowing the product to be legally sold in the EU market. Non-compliance could result in the app being illegal to use in the EU and open the manufacturer to fines or product liability.
FDA Regulation of Mobile Medical ApplicationsMichael Swit
This document provides an overview of the FDA's regulation of mobile medical applications. It summarizes the FDA's 2013 guidance which established three categories for mobile medical apps: 1) those not considered medical devices, 2) those considered medical devices but subject to enforcement discretion due to low risk, and 3) those considered medical devices subject to FDA regulation due to higher risk. It describes the types of apps that fall into each category and provides examples. It also discusses a recent 2014 draft guidance relating to medical device data systems.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Medical Device Cybersecurity : A Regulatory PerspectiveJon Lendrum
The document summarizes a presentation on cybersecurity regulations for medical devices. It discusses how the FDA regulates cybersecurity through guidance documents and interpretations of quality system regulations, despite no explicit authority. The presentation reviews FDA recommendations for documenting cybersecurity in premarket submissions and debunks common myths. Senator Blumenthal introduced legislation to further require cybersecurity testing and transparency.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
Unisys Integrated Medical Device Management - Executive BriefUnisys Corporation
The document discusses the Unisys Integrated Medical Device Management (IMDM) solution. IMDM allows healthcare organizations to (1) monitor and manage all medical devices from a single system, (2) simplify device recalls and maintenance, and (3) maintain compliance through embedded security and traceable workflows. IMDM incorporates device data and analytics to provide visibility into device performance and issues.
2016 PLCT PPT - PRODUCT MALFUNCTION THEORY WHEN “SMART” PRODUCTS ACT DUMBRob Smith
1) Smart products and internet connected devices are increasingly common but can malfunction in ways that compromise user safety and privacy.
2) Mobile medical apps are regulated by the FDA depending on their intended use and risk level, from full regulation as medical devices to enforcement discretion for lower risk apps.
3) Autonomous vehicles offer safety and mobility benefits but also cybersecurity, liability, and insurance challenges that must be addressed as the technology develops.
This document provides an overview and introduction to ISO/IEC 80001-1, which establishes a risk management framework for IT networks incorporating medical devices. It describes why the standard was created, as networks are becoming more complex and integrated. ISO/IEC 80001-1 aims to ensure the safety, effectiveness, and security of medical IT networks by defining roles and responsibilities for manufacturers, healthcare organizations, and regulators during the risk management process. It also introduces the new role of a "Medical IT-Network Risk Manager" within healthcare organizations to help manage risks and communication relating to networked medical devices.
Digital Health and Remote Monitoring Devices: the Impact of COVID-19 on Their...Greenlight Guru
This session focuses on a few case studies for how device companies were impacted by three FDA guidance documents. Allison Komiyama, PhD, RAC, Principal Consultant at AcKnowledge Regulatory Strategies will highlight pros and cons for each.
The FDA Guidance Documents to be discussed:
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019
• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019
• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
IRJET - Medicine Reminder System using IoTIRJET Journal
This document describes a proposed medicine reminder system using IoT. The system uses an Arduino microcontroller with an EEPROM and buzzer circuit to provide reminders to patients to take their medications at scheduled times. An alarm will sound if the scheduled time matches the real-world clock, and the patient must press a button within a certain time to acknowledge taking their medication. If they do not, an SMS will be sent to their caregiver. The system aims to help patients take their medications correctly and on time through these reminders and monitoring functionality. It could also track medication intake levels and patient health data over time.
IRJET- An Android Application for Electronic Health Record SystemIRJET Journal
This document proposes an Android application for an electronic health record (EHR) system. It summarizes that EHR systems use digital records rather than paper to store patient health information like medical history, appointments, lab results, and more. The proposed application would allow patients to book appointments with doctors and view their health records on their phones. It would also give patients the ability to manually enter blood pressure and sugar levels. Doctors could use the app to view patient appointment schedules and send prescriptions. The application aims to improve healthcare services and efficiency by making records easily accessible to both patients and doctors.
The proposed revisions to AAAHC standards for 2010 include a new core Chapter 7 that will consist of two subchapters: Subchapter I on Infection Control and Prevention, and Subchapter II on Safety. The most significant proposed changes are outlined for each subchapter, including requirements for infection prevention programs, sharps injury prevention, environmental safety, emergency preparedness, and recall of medical devices. The Texas Administrative Code Rule §135.27 on patient safety programs is also summarized, outlining requirements for adverse event reporting, root cause analysis, and management of reportable events.
The Electronic Health Record (EHR) is a longitudinal electronic record of patient health
information generated by one or more encounters in any care delivery setting. Included in this
information are patient demographics, progress notes, problems, medications, vital signs, past
medical history, immunizations, laboratory data, and radiology reports. The EHR automates and
streamlines the clinician's workflow. The EHR has the ability to generate a complete record of a
clinical patient encounter, as well as supporting other care-related activities directly or indirectly
via interface including evidence-based decision support, quality management, and outcomes
reporting.
This document provides information on various data sources that feed into the Mount Sinai Data Warehouse (MSDW). It lists the following internal systems: Cerner, IDX Flowcast, EPIC, SCC, IDXRAD, PowerPath/Tamtron, HSM, Cardiac Cath, EKG (Muse), and CompuRecord. It also lists the following external data sets: National Death Index and Press Ganey Satisfaction Score. It then provides more detailed information about the Cerner, IDX Flowcast, EPIC, SCC Lab, IDXRAD, PowerPath, and HSM systems, including the types of data each system captures and how that data is integrated into the MSDW
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.
TGA webinar presentation: Regulation of software, including software as a med...TGA Australia
This document provides an overview of medical device regulation in Australia, including regulation of software as a medical device (SaMD). It discusses the four key steps in medical device regulation: 1) risk-based classification, 2) conformity assessment procedures, 3) inclusion in the Australian Register of Therapeutic Goods, and 4) post-market monitoring and reporting. International approaches to SaMD regulation from Europe, the US, and proposed reforms in Australia are also covered. The presentation aims to explain how SaMD is regulated based on its intended use and potential risks to ensure safety while allowing innovation.
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.
Mobile Medical Apps and FDA Regulatory ApproachAkshay Anand
A presentation on Food Safety and Standards Authority of India. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015
This document summarizes key aspects of legal and regulatory issues related to medical device software in the European Union. It discusses when software is considered a medical device and must be CE marked. It also outlines manufacturer obligations, classification rules, standards and guidance, clinical evaluation requirements, and emerging issues around networked devices and eHealth.
This document discusses when a mobile app would be considered a medical device and require CE marking under the European Medical Devices Directive. An app is a medical device if it is intended by its manufacturer to be used for medical purposes like diagnosis, treatment or monitoring of disease. Standalone medical software or software incorporated into a medical device would require CE marking. The document outlines the classification process for medical devices and implications of CE marking, including meeting essential safety requirements and allowing the product to be legally sold in the EU market. Non-compliance could result in the app being illegal to use in the EU and open the manufacturer to fines or product liability.
FDA Regulation of Mobile Medical ApplicationsMichael Swit
This document provides an overview of the FDA's regulation of mobile medical applications. It summarizes the FDA's 2013 guidance which established three categories for mobile medical apps: 1) those not considered medical devices, 2) those considered medical devices but subject to enforcement discretion due to low risk, and 3) those considered medical devices subject to FDA regulation due to higher risk. It describes the types of apps that fall into each category and provides examples. It also discusses a recent 2014 draft guidance relating to medical device data systems.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Medical Device Cybersecurity : A Regulatory PerspectiveJon Lendrum
The document summarizes a presentation on cybersecurity regulations for medical devices. It discusses how the FDA regulates cybersecurity through guidance documents and interpretations of quality system regulations, despite no explicit authority. The presentation reviews FDA recommendations for documenting cybersecurity in premarket submissions and debunks common myths. Senator Blumenthal introduced legislation to further require cybersecurity testing and transparency.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
Unisys Integrated Medical Device Management - Executive BriefUnisys Corporation
The document discusses the Unisys Integrated Medical Device Management (IMDM) solution. IMDM allows healthcare organizations to (1) monitor and manage all medical devices from a single system, (2) simplify device recalls and maintenance, and (3) maintain compliance through embedded security and traceable workflows. IMDM incorporates device data and analytics to provide visibility into device performance and issues.
2016 PLCT PPT - PRODUCT MALFUNCTION THEORY WHEN “SMART” PRODUCTS ACT DUMBRob Smith
1) Smart products and internet connected devices are increasingly common but can malfunction in ways that compromise user safety and privacy.
2) Mobile medical apps are regulated by the FDA depending on their intended use and risk level, from full regulation as medical devices to enforcement discretion for lower risk apps.
3) Autonomous vehicles offer safety and mobility benefits but also cybersecurity, liability, and insurance challenges that must be addressed as the technology develops.
This document provides an overview and introduction to ISO/IEC 80001-1, which establishes a risk management framework for IT networks incorporating medical devices. It describes why the standard was created, as networks are becoming more complex and integrated. ISO/IEC 80001-1 aims to ensure the safety, effectiveness, and security of medical IT networks by defining roles and responsibilities for manufacturers, healthcare organizations, and regulators during the risk management process. It also introduces the new role of a "Medical IT-Network Risk Manager" within healthcare organizations to help manage risks and communication relating to networked medical devices.
Digital Health and Remote Monitoring Devices: the Impact of COVID-19 on Their...Greenlight Guru
This session focuses on a few case studies for how device companies were impacted by three FDA guidance documents. Allison Komiyama, PhD, RAC, Principal Consultant at AcKnowledge Regulatory Strategies will highlight pros and cons for each.
The FDA Guidance Documents to be discussed:
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019
• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019
• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
IRJET - Medicine Reminder System using IoTIRJET Journal
This document describes a proposed medicine reminder system using IoT. The system uses an Arduino microcontroller with an EEPROM and buzzer circuit to provide reminders to patients to take their medications at scheduled times. An alarm will sound if the scheduled time matches the real-world clock, and the patient must press a button within a certain time to acknowledge taking their medication. If they do not, an SMS will be sent to their caregiver. The system aims to help patients take their medications correctly and on time through these reminders and monitoring functionality. It could also track medication intake levels and patient health data over time.
IRJET- An Android Application for Electronic Health Record SystemIRJET Journal
This document proposes an Android application for an electronic health record (EHR) system. It summarizes that EHR systems use digital records rather than paper to store patient health information like medical history, appointments, lab results, and more. The proposed application would allow patients to book appointments with doctors and view their health records on their phones. It would also give patients the ability to manually enter blood pressure and sugar levels. Doctors could use the app to view patient appointment schedules and send prescriptions. The application aims to improve healthcare services and efficiency by making records easily accessible to both patients and doctors.
The proposed revisions to AAAHC standards for 2010 include a new core Chapter 7 that will consist of two subchapters: Subchapter I on Infection Control and Prevention, and Subchapter II on Safety. The most significant proposed changes are outlined for each subchapter, including requirements for infection prevention programs, sharps injury prevention, environmental safety, emergency preparedness, and recall of medical devices. The Texas Administrative Code Rule §135.27 on patient safety programs is also summarized, outlining requirements for adverse event reporting, root cause analysis, and management of reportable events.
The Electronic Health Record (EHR) is a longitudinal electronic record of patient health
information generated by one or more encounters in any care delivery setting. Included in this
information are patient demographics, progress notes, problems, medications, vital signs, past
medical history, immunizations, laboratory data, and radiology reports. The EHR automates and
streamlines the clinician's workflow. The EHR has the ability to generate a complete record of a
clinical patient encounter, as well as supporting other care-related activities directly or indirectly
via interface including evidence-based decision support, quality management, and outcomes
reporting.
This document provides information on various data sources that feed into the Mount Sinai Data Warehouse (MSDW). It lists the following internal systems: Cerner, IDX Flowcast, EPIC, SCC, IDXRAD, PowerPath/Tamtron, HSM, Cardiac Cath, EKG (Muse), and CompuRecord. It also lists the following external data sets: National Death Index and Press Ganey Satisfaction Score. It then provides more detailed information about the Cerner, IDX Flowcast, EPIC, SCC Lab, IDXRAD, PowerPath, and HSM systems, including the types of data each system captures and how that data is integrated into the MSDW
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.
TGA webinar presentation: Regulation of software, including software as a med...TGA Australia
This document provides an overview of medical device regulation in Australia, including regulation of software as a medical device (SaMD). It discusses the four key steps in medical device regulation: 1) risk-based classification, 2) conformity assessment procedures, 3) inclusion in the Australian Register of Therapeutic Goods, and 4) post-market monitoring and reporting. International approaches to SaMD regulation from Europe, the US, and proposed reforms in Australia are also covered. The presentation aims to explain how SaMD is regulated based on its intended use and potential risks to ensure safety while allowing innovation.
Cathal Brennan , Medical Device Assessor- Human Products Authorisation and Re...Investnet
This document discusses the regulation of standalone software as a medical device. It begins by defining standalone software and noting the EU directive that amended the definition of a medical device to include software intended for medical purposes. It then covers how to qualify standalone software as a medical device and classify it. The document reviews essential requirements, harmonized standards, conformity assessment procedures including CE marking, and registration requirements. It provides advice for manufacturers on ensuring compliance and for users on reporting issues. The role of the Irish regulator HPRA in providing guidance and conducting oversight is also discussed.
Medical devices keep evolving, and with cutting edge technologies such as AI and Cloud, they are continuously adding quality to the overall patient care. Being in the medical sector, where the patient and their care is always a priority, manufacturers are required to follow the FDA regulatory guidelines which ensure that their devices are qualified enough to be released in the market. When it comes to FDA approval, it is essential to know the class of the device. The device class is one factor in determining the regulatory pathway and therefore, identifying the medical device class is a vital first step in the FDA medical device approval process...
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
This document discusses medical device regulation and classification. It begins by defining medical devices and the purpose of regulation. Devices are classified by invasiveness, duration of use, and anatomical site into Class I, II, and III. Class I devices have the lowest risk, while Class III devices like pacemakers have higher risks. Marketing approval processes vary by class, from general controls for Class I, to 510(k) notifications for Class II that demonstrate substantial equivalence, to stringent Pre-Market Approval (PMA) required for new Class III devices which requires clinical trial data. The document also covers international standards, design control, risk management including failure mode and effect analysis, and risk control methods.
This document discusses the development and regulatory requirements for digital therapeutics. It begins by defining key terms like digital health, digital medicine, and digital therapeutics. It then discusses the differences between digital solutions and digital therapies and provides examples of each. It outlines the regulatory landscape for digital therapeutics and software as a medical device, including FDA guidance and approval pathways. It also discusses collecting real-world data to monitor digital therapeutic performance after market approval.
Due to advancement of technology and incorporation of sofrtwares and microchips, vulnerability increased for medical devices.
Outsiders are hacking the devices by advanced technologies.
Medical Device FDA Regulations and Classifications infographicKathleen Murray
Infographic describing how the FDA classifies and regulates medical devices from life saving and sustaining devices to medical devices you use every day
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.
An Extended Notation of FTA for Risk Assessment of Software-intensive Medical...Yoshio SAKAI
An extended notation of FTA for risk assessment of software-intensive medical devices
Yoshio Sakai, Seiko Shirasaka and Yasuharu Nishi
It is difficult to assess the risk of software-intensive medical devices. An extended notation of FTA recognizes the risk class before and after the risk control measure and the software in the system affects the top event of FTA.
You can see this content as 6-pages paper from IEEE Website.
Risk management in development of life critical systemsScott Althouse
The document discusses risk management best practices for developing life critical systems and medical devices. It defines key safety concepts like hazards, risks, and failures. It recommends performing risk analysis early in development using methods like FMEA. It also advocates for model-driven development practices like requirements management, system modeling, and automated document generation to improve safety, quality, and compliance. Success stories are provided of medical device companies using IBM Rational solutions to develop smarter and safer products.
Understanding Cybersecurity in Medical Devices and ApplicationsEMMAIntl
One of the major pillars of the current Industry 4.0 is Automation. Indeed, technology is intervening in almost every domain to “automate” the workforce and make human life easier and better. In the present age, machines are getting integrated with the Internet of Things, Cloud Computing, and Artificial Intelligence with the data flow being transferred and processed via the Internet. These changes indeed catalyze the overall productivity, but also expose data to the public
domains.
In cases of continuous data transfers and exposition, Cybersecurity becomes a pivotal element where it not only protects the data but also proactively provides mechanisms to defend against malicious attacks and malware. In the case of medical devices that include sensitive medical data flows and software-controlled hardware devices like heart implants or Continuous Glucose Monitoring (CGM) devices, Cybersecurity becomes an important factor for contributing towards system safety and quality...
Safety monitoring and reporting of adverse events of medical devices national...Vivek Nayak
This document outlines safety monitoring and adverse event reporting for medical devices from national and international perspectives. It defines medical devices and their classification system. Approval processes in India are discussed, along with the Materiovigilance Program of India for post-marketing surveillance. Adverse events must be reported within defined timeframes. International regulatory bodies like the FDA and MHRA also have mandatory reporting requirements. The limitations of current monitoring and reporting are noted.
Outstanding innovations come with the heavy burden of dealing with new risks and threats. Especially when public health is at risk, FDA and other regulatory agencies attempt to provide guidance for companies to develop safe and effective products. With all the technological advancements in the digital health arena, medical devices are susceptible to attacks by hackers...
Presentation: The challenges of regulating direct to consumer digital medical...TGA Australia
The document discusses the challenges of regulating direct-to-consumer digital medical devices. It describes what digital medical devices are, including connected devices, telehealth, apps, and wearables. The Therapeutic Goods Administration (TGA) regulates medical devices in Australia to ensure they are safe and effective. However, digital devices pose new challenges as many are software-based and consumers may not understand their intended medical purpose. The TGA must determine how to appropriately apply existing regulations to these new technologies.
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
This document discusses mobile health (mHealth) applications and devices. It defines mHealth as including diagnostic tools, electronic health records, picture archiving and communication systems, education programs, epidemic tracking, and telemedicine accessed through mobile phones and other devices. The document notes the growth of the mHealth market and opportunities it provides for remote monitoring, personalized therapy and reducing healthcare costs. However, it also discusses challenges like a lack of standards, security concerns, and risks associated with personal devices being used for healthcare. It reviews regulations around mHealth in Europe and the United States and examples of mHealth apps and devices that have been cleared or approved in those markets.
Breakout Session: Cybersecurity in Medical DevicesHealthegy
Presentation by PwC at Medtech Conference 2016.
Participant:
Geoff Fisher, Director – PwC
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For more healthcare innovation
Visit us at Healthegy.com
Similar to EU 2017/745 Rule 11 (re)interpretation (20)
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I express my personal point of view about the Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
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1. The document discusses significant changes in medical device software design and intended purpose according to the Medical Device Regulation (MDR). It notes that software changes that modify algorithms, database structures, operating platforms, architecture, user interfaces, or interoperability channels require a new UDI.
2. Guidance is provided on assessing whether software changes are significant based on factors like performance, safety, intended use, and data interpretation. Examples are given of specifying performance and safety tolerances.
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This document discusses converting Oracle Forms code to Delphi code. It describes using the Forms2XML tool to convert Forms code to XML, then using the Virgilio tool to convert the XML to Delphi code like dfm, pas, and dpr files. An example of generated Delphi code from converting a tree application is shown, including code to declare variables and find properties of a tree node like the employee number and name. The next steps will be to build a real application in Delphi.
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This document discusses automatically converting Oracle Forms code to Delphi code. It notes some issues with running Oracle Forms applications using Java applets, including performance problems and lack of support in modern browsers. It then describes how converting the code to Delphi allows running it as a native Windows/Mac/iOS application or as a web application using HTML5. This provides benefits like faster performance, support on all browsers, and the ability to reuse the same code and database on different platforms. It also explains the conversion process aims to maintain the structure and naming of the original PL/SQL code.
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The document discusses AAMI TIR 57, which provides guidance on bi-dimensional risk analysis for medical devices that considers both security and safety risks. It notes that threats and vulnerabilities are often discovered after a device is released, so security risks must be continually evaluated. The document advocates using a customized "LEGO-like" operating system with advanced process management, firewall whitelisting, and minimized components to reduce cybersecurity risks and eliminate the need for operating system upgrades. This customized approach aims to create a more stable, secure system focused only on approved medical device processes.
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Explore the groundbreaking work of Dr. David Greene, a pioneer in regenerative medicine, who is revolutionizing the field of cardiology through stem cell therapy in Arizona. This ppt delves into how Dr. Greene's innovative approach is providing non-surgical, effective treatments for heart disease, using the body's own cells to repair heart damage and improve patient outcomes. Learn about the science behind stem cell therapy, its benefits over traditional cardiac surgeries, and the promising future it holds for modern medicine. Join us as we uncover how Dr. Greene's commitment to stem cell research and therapy is setting new standards in healthcare and offering new hope to cardiac patients.
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)bkling
Your mindset is the way you make sense of the world around you. This lens influences the way you think, the way you feel, and how you might behave in certain situations. Let's talk about mindset myths that can get us into trouble and ways to cultivate a mindset to support your cancer survivorship in authentic ways. Let’s Talk About It!
International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
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1. 1
EU 2017/745 Rule 11 (re)interpretation :
When Medical Device Software is
classified as class III (with Example)
Antonio Bartolozzi
antonio.bartolozzi@bartolozzi.it 12/05/2019
2. 2antonio.bartolozzi@bartolozzi.it
Rule 11
Software intended to provide information which is used to take decisions with
diagnosis or therapeutic purposes is classified as class IIa, except if such
decisions have an impact that may cause:
• death or an irreversible deterioration of a person's state of health, in
which case it is in class III; or
• a serious deterioration of a person's state of health or a surgical
intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa,
except if it is intended for monitoring of vital physiological parameters, where
the nature of variations of those parameters is such that it could result in
immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I
THE PROBLEM
3. 3antonio.bartolozzi@bartolozzi.it
EN 62304 : 2015 Class C
The SOFTWARE SYSTEM is software safety class C if:
• the SOFTWARE SYSTEM can contribute to a
HAZARDOUS SITUATION which results in
unacceptable RISK after consideration of RISK
CONTROL measures external to the SOFTWARE
SYSTEM and the resulting possible HARM is death
or SERIOUS INJURY.
4. 4antonio.bartolozzi@bartolozzi.it
Disambiguating MDR via EN62304
… have an impact that may cause …
… contribute to a HAZARDOUS SITUATION which results in
unacceptable RISK after consideration of RISK CONTROL
measures external to the SOFTWARE SYSTEM
and the
resulting possible HARM
is …
EN
62304:2015
EN 62304:2006 is a harmonized standards under the MDR and MDD.
EN 62304:2015 is a European Standard “carries with it the obligation to be
implemented at national level by being given the status of a national
standard and by withdrawal of any conflicting national standard".
use EN standards to interpret MDR
meaning !
DO NOT USE FOR CLASSIFICATION !
MDR
that
may
cause
impact
used to indicate possibility
or probability
a significant or major effect
5. 5antonio.bartolozzi@bartolozzi.it
Rule 11 after EN 62304:2015 filter
Software intended to provide information which is used to
take decisions with diagnosis or therapeutic purposes that is
classified as class IIa, except if such decisions can contribute to a
HAZARDOUS SITUATION which results in unacceptable RISK
after consideration of RISK CONTROL measures external to the
SOFTWARE SYSTEM and the resulting possible HARM is :
• death or an irreversible deterioration of a person's state of
health, in which case it is in class III;
• Or a serious deterioration of a person's state of health or a
surgical intervention, in which case it is classified as class
IIb.
MAY CAUSE
IMPACTdisambiguate
disambiguate
6. 6antonio.bartolozzi@bartolozzi.it
HOW classify
In determining the software safety classification of the SOFTWARE SYSTEM :
Probability of a software failure shall be assumed lo be 1.
Only RISK CONTROL implemented within (external to) the SOFTWARE
SYSTEM shall be considered.
NOTE Such RISK CONTROL measures may reduce the probability that a
software failure will cause HARM and/or the severity of that HARM.
EN 62304:2015
8. 8antonio.bartolozzi@bartolozzi.it
How declassify
For a SOFTWARE SYSTEM initially classified as software
safety class B or C, the MANUFACTURER may implement
additional RISK CONTROL measures external to the
SOFTWARE SYSTEM (including revising the system
architecture containing the SOFTWARE SYSTEM) and
subsequently assign a new software safety classification
to the SOFTWARE SYSTEM.
EN 62304:2015
10. 10antonio.bartolozzi@bartolozzi.it
What does «class III» mean?
Class III = there is unacceptable RISK (when Probability of a
software failure is assumed to be 1) after consideration of RISK
CONTROL measures external to the SOFTWARE SYSTEM
to cause death or an irreversible deterioration of a
person's state of health.
(for every possible software bug)
Is there a unacceptable RISK - of death or
an irreversible deterioration of a person's
state of health - after consideration of
RISK CONTROL measures external to the
SOFTWARE SYSTEM?
whatever can go wrong, will go wrongApply Murphy’s Law to our software
YES CLASS III
EN62304:2015: Probability of a software
failure shall be assumed to be 1.
11. 11antonio.bartolozzi@bartolozzi.it
SOFTWARE SYSTEM
Classification Example
Therapy or radiation planning software (SW1)
Software intended to provide information which is used to take decisions with
diagnosis or therapeutic purposes
… may cause death or an irreversible deterioration of a person's state of
health …
Class III MDR
+
Safety Class C EN62304
SW1
Class C
Class III
there is unacceptable RISK after
consideration of RISK CONTROL measures
external to the SOFTWARE SYSTEM to
cause death or an irreversible deterioration
of a person's state of health
12. 12antonio.bartolozzi@bartolozzi.it
Re-Classification Example
Therapy or radiation planning software
software system (class I / IIb)
External software which check
output data (external risk control)
NO inacceptable RISK (death or an irreversible deterioration of a
person's state of health) after consideration of RISK CONTROL
measures external to the SOFTWARE SYSTEM
Class C EN62304Class B EN62304
SW1
Class B
SW1 SW2
SW2
Class C
Alarm
Segregation
software safety class
based on the risk
that the risk control
measure is
controlling .
Rule 7.7.2 EN62304:2015
Declassified
Class I (MDR)
Class I/IIb (MDR)
Paradox:
SW2 is class I (MDR)
with a safety class C
(EN62304)
Software System