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.
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.
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.
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.
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.
But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?
In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.
About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.
About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
Cliniminds- Skill Development Program in PharmacovigilanceCliniminds India
CLINIMINDS brings to you an intensive course covering all the aspects of case processing, specially designed for Pharmacovigilance professional.
Our training program involves:
1. Fresher training for Drug Safety Associate with Hands On experience on safety database
2. Training on Case Processing
3. Training on Aggregate Reporting with Hands On
experience in PSUR/ PBRER writing
4. Training on Signal Detection and Risk Management
5. Training on Regulatory Affairs on Audits
6. Training Medical and Scientific Content Writing
7. Customized Training on Pharmacovigilance (Designed exclusively for Corporate who need domain knowledge on specific area (s) of pharmacovigilance)
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
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.
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
Tools Available to the FDA to Assess Patient SafetyEMMAIntl
Patient Safety must be at the center point of all operations in the health care industry. Whether it is the manufacturer who is responsible for designing and developing the drug or the device, doctors and nurses administering the drug or the device, or the FDA who is responsible for regulating the use of such products on patients...
A Survey on Current Applications for Tracking COVID-19EMMAIntl
The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and organizations such as World Health Organization (WHO), European Medical Agency (EMA), and FDA are working together to eliminate lockdowns and get our society back up and running. In such cases, several companies, firms, and universities have found opportunities to provide critical services such as virus detection, tracking, data-driven decision-making algorithms, and visual analytic applications...
Presentation: Medical Devices: how to stay included workshop - Adverse event ...TGA Australia
This presentation discusses adverse event reporting including identification and reporting of adverse events, recognising avoidable errors and the difference in reporting requirements for SAS and clinical trial devices.
Risk managements documents required for the market placement of a medical dev...PEPGRA Healthcare
• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.
• Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.
• For medicinal products the risk management documents/plan is achieved by
• If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP)
To Continue reading : https://bit.ly/3e1harA
Contact us;
website: https://bit.ly/2W1nV6r
Email: sales.cro@pepgra.com
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.
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.
But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?
In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.
About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.
About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
Cliniminds- Skill Development Program in PharmacovigilanceCliniminds India
CLINIMINDS brings to you an intensive course covering all the aspects of case processing, specially designed for Pharmacovigilance professional.
Our training program involves:
1. Fresher training for Drug Safety Associate with Hands On experience on safety database
2. Training on Case Processing
3. Training on Aggregate Reporting with Hands On
experience in PSUR/ PBRER writing
4. Training on Signal Detection and Risk Management
5. Training on Regulatory Affairs on Audits
6. Training Medical and Scientific Content Writing
7. Customized Training on Pharmacovigilance (Designed exclusively for Corporate who need domain knowledge on specific area (s) of pharmacovigilance)
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
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.
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
Tools Available to the FDA to Assess Patient SafetyEMMAIntl
Patient Safety must be at the center point of all operations in the health care industry. Whether it is the manufacturer who is responsible for designing and developing the drug or the device, doctors and nurses administering the drug or the device, or the FDA who is responsible for regulating the use of such products on patients...
A Survey on Current Applications for Tracking COVID-19EMMAIntl
The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and organizations such as World Health Organization (WHO), European Medical Agency (EMA), and FDA are working together to eliminate lockdowns and get our society back up and running. In such cases, several companies, firms, and universities have found opportunities to provide critical services such as virus detection, tracking, data-driven decision-making algorithms, and visual analytic applications...
Presentation: Medical Devices: how to stay included workshop - Adverse event ...TGA Australia
This presentation discusses adverse event reporting including identification and reporting of adverse events, recognising avoidable errors and the difference in reporting requirements for SAS and clinical trial devices.
Risk managements documents required for the market placement of a medical dev...PEPGRA Healthcare
• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.
• Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.
• For medicinal products the risk management documents/plan is achieved by
• If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP)
To Continue reading : https://bit.ly/3e1harA
Contact us;
website: https://bit.ly/2W1nV6r
Email: sales.cro@pepgra.com
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
provide condence to the clinicians and the patients that the medical devices and the implantable devices used in the region have been validated for their potential benets and certied as safe for usage.
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
Due to advancement of technology and incorporation of sofrtwares and microchips, vulnerability increased for medical devices.
Outsiders are hacking the devices by advanced technologies.
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
Breakout Session: Cybersecurity in Medical DevicesHealthegy
Presentation by PwC at Medtech Conference 2016.
Participant:
Geoff Fisher, Director – PwC
Powered by:
Healthegy
For more healthcare innovation
Visit us at Healthegy.com
NHS England share Code4Health ChallengeHANDI HEALTH
The NHS England Open Source Programme is creating a diverse range of solutions to increase choice, improve clinical practice and enhance patient engagement, including EHR, ePrescribing, departmental systems such as electronic observations, ophthalmology and integrated cross community portal solutions.
HANDI Summit 18 - Introducing HANDI-HOPD - Ewan DavisHANDI HEALTH
NHS England hosted the HANDI-HOPD Summit in London on the 18th September. This was attended by an invited audience of around 40 people to discuss plans to take the HANDI-HOPD platform forward to the NHS England Open Source Open Day on the 26th of November in Newcastle-Upon-Tyne where is will be launched as the Platform for NHS Code4Health.
HANDI-HOPD The HANDI Open Platform Demonstrator provides an experimental platform to demonstrate the power of emerging open standards and APIs to deliver the transformational power of the Internet to support digital health and care.
Ewan Davis introduced the HOPD, described where it fitted in the global development of open health platforms what had already been deployed and our plans for it’s development.
HANDI Summit 18 - Introducing HANDI-HOPD - Dr Ian McNicollHANDI HEALTH
NHS England hosted the HANDI-HOPD Summit in London on the 18th September. This was attended by an invited audience of around 40 people to discuss plans to take the HANDI-HOPD platform forward to the NHS England Open Source Open Day on the 26th of November in Newcastle-Upon-Tyne where is will be launched as the Platform for NHS Code4Health.
Dr Ian McNicoll, gave an overview of how the platform worked and a description of the key open standards and how the could be used by developers to rapidly build interoperable health and care software. He also described how the platform provided a rigorous process fro the development, curation and publication of clinical content models and facilitated the easy engagement of clinicians in the process.
PHP Frameworks: I want to break free (IPC Berlin 2024)Ralf Eggert
In this presentation, we examine the challenges and limitations of relying too heavily on PHP frameworks in web development. We discuss the history of PHP and its frameworks to understand how this dependence has evolved. The focus will be on providing concrete tips and strategies to reduce reliance on these frameworks, based on real-world examples and practical considerations. The goal is to equip developers with the skills and knowledge to create more flexible and future-proof web applications. We'll explore the importance of maintaining autonomy in a rapidly changing tech landscape and how to make informed decisions in PHP development.
This talk is aimed at encouraging a more independent approach to using PHP frameworks, moving towards a more flexible and future-proof approach to PHP development.
Essentials of Automations: Optimizing FME Workflows with ParametersSafe Software
Are you looking to streamline your workflows and boost your projects’ efficiency? Do you find yourself searching for ways to add flexibility and control over your FME workflows? If so, you’re in the right place.
Join us for an insightful dive into the world of FME parameters, a critical element in optimizing workflow efficiency. This webinar marks the beginning of our three-part “Essentials of Automation” series. This first webinar is designed to equip you with the knowledge and skills to utilize parameters effectively: enhancing the flexibility, maintainability, and user control of your FME projects.
Here’s what you’ll gain:
- Essentials of FME Parameters: Understand the pivotal role of parameters, including Reader/Writer, Transformer, User, and FME Flow categories. Discover how they are the key to unlocking automation and optimization within your workflows.
- Practical Applications in FME Form: Delve into key user parameter types including choice, connections, and file URLs. Allow users to control how a workflow runs, making your workflows more reusable. Learn to import values and deliver the best user experience for your workflows while enhancing accuracy.
- Optimization Strategies in FME Flow: Explore the creation and strategic deployment of parameters in FME Flow, including the use of deployment and geometry parameters, to maximize workflow efficiency.
- Pro Tips for Success: Gain insights on parameterizing connections and leveraging new features like Conditional Visibility for clarity and simplicity.
We’ll wrap up with a glimpse into future webinars, followed by a Q&A session to address your specific questions surrounding this topic.
Don’t miss this opportunity to elevate your FME expertise and drive your projects to new heights of efficiency.
Kubernetes & AI - Beauty and the Beast !?! @KCD Istanbul 2024Tobias Schneck
As AI technology is pushing into IT I was wondering myself, as an “infrastructure container kubernetes guy”, how get this fancy AI technology get managed from an infrastructure operational view? Is it possible to apply our lovely cloud native principals as well? What benefit’s both technologies could bring to each other?
Let me take this questions and provide you a short journey through existing deployment models and use cases for AI software. On practical examples, we discuss what cloud/on-premise strategy we may need for applying it to our own infrastructure to get it to work from an enterprise perspective. I want to give an overview about infrastructure requirements and technologies, what could be beneficial or limiting your AI use cases in an enterprise environment. An interactive Demo will give you some insides, what approaches I got already working for real.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing – with little to no training required
Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
👨🏫 Andras Palfi, Senior Product Manager, UiPath
👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
Software Delivery At the Speed of AI: Inflectra Invests In AI-Powered QualityInflectra
In this insightful webinar, Inflectra explores how artificial intelligence (AI) is transforming software development and testing. Discover how AI-powered tools are revolutionizing every stage of the software development lifecycle (SDLC), from design and prototyping to testing, deployment, and monitoring.
Learn about:
• The Future of Testing: How AI is shifting testing towards verification, analysis, and higher-level skills, while reducing repetitive tasks.
• Test Automation: How AI-powered test case generation, optimization, and self-healing tests are making testing more efficient and effective.
• Visual Testing: Explore the emerging capabilities of AI in visual testing and how it's set to revolutionize UI verification.
• Inflectra's AI Solutions: See demonstrations of Inflectra's cutting-edge AI tools like the ChatGPT plugin and Azure Open AI platform, designed to streamline your testing process.
Whether you're a developer, tester, or QA professional, this webinar will give you valuable insights into how AI is shaping the future of software delivery.
Connector Corner: Automate dynamic content and events by pushing a buttonDianaGray10
Here is something new! In our next Connector Corner webinar, we will demonstrate how you can use a single workflow to:
Create a campaign using Mailchimp with merge tags/fields
Send an interactive Slack channel message (using buttons)
Have the message received by managers and peers along with a test email for review
But there’s more:
In a second workflow supporting the same use case, you’ll see:
Your campaign sent to target colleagues for approval
If the “Approve” button is clicked, a Jira/Zendesk ticket is created for the marketing design team
But—if the “Reject” button is pushed, colleagues will be alerted via Slack message
Join us to learn more about this new, human-in-the-loop capability, brought to you by Integration Service connectors.
And...
Speakers:
Akshay Agnihotri, Product Manager
Charlie Greenberg, Host
Builder.ai Founder Sachin Dev Duggal's Strategic Approach to Create an Innova...Ramesh Iyer
In today's fast-changing business world, Companies that adapt and embrace new ideas often need help to keep up with the competition. However, fostering a culture of innovation takes much work. It takes vision, leadership and willingness to take risks in the right proportion. Sachin Dev Duggal, co-founder of Builder.ai, has perfected the art of this balance, creating a company culture where creativity and growth are nurtured at each stage.
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
GraphRAG is All You need? LLM & Knowledge GraphGuy Korland
Guy Korland, CEO and Co-founder of FalkorDB, will review two articles on the integration of language models with knowledge graphs.
1. Unifying Large Language Models and Knowledge Graphs: A Roadmap.
https://arxiv.org/abs/2306.08302
2. Microsoft Research's GraphRAG paper and a review paper on various uses of knowledge graphs:
https://www.microsoft.com/en-us/research/blog/graphrag-unlocking-llm-discovery-on-narrative-private-data/
Let's dive deeper into the world of ODC! Ricardo Alves (OutSystems) will join us to tell all about the new Data Fabric. After that, Sezen de Bruijn (OutSystems) will get into the details on how to best design a sturdy architecture within ODC.
"Impact of front-end architecture on development cost", Viktor TurskyiFwdays
I have heard many times that architecture is not important for the front-end. Also, many times I have seen how developers implement features on the front-end just following the standard rules for a framework and think that this is enough to successfully launch the project, and then the project fails. How to prevent this and what approach to choose? I have launched dozens of complex projects and during the talk we will analyze which approaches have worked for me and which have not.
1. Apps to Transform Health and Care – That’s
HANDI
www.handihealth.org
HANDIHealth Community Interest Company
2. Why HANDI?
Because we believe apps and the app
paradigm can transform health and care
3. Dr Neill Jones
General Practitioner
Clinical Informatician
Ex Clinical Director FDBE
− took product through the MDD
4. Medical device directive and the implications for
Medical APPS
Outline of the Presentation
Medical Device Directive
Clinical Safety
Quality management systems
What is a medical device
What you need to do
Definitions and concepts
5. Medical Devices Directive 93/42/EEC
Requires manufacturers placing medical
device(s) on the Community market
Provide certain information to a Competent
Authority in a Member State where they
have a registered place of business.
6. Medical Device:
any instrument, apparatus, appliance,
software, material or other article, whether
used alone or in combination, including the
software intended by its manufacturer to be
used specifically for diagnostic and/or
therapeutic purposes and necessary for its
proper application, intended by the
manufacturer to be used for human beings
for the purpose of:
7. Purpose of:
diagnosis, prevention, monitoring,
treatment or alleviation of disease,
diagnosis, monitoring, treatment,
alleviation of or compensation for an injury
or handicap,
investigation, replacement or modification
of the anatomy or of a physiological
process,
8. control of conception
which does not achieve its principal intended
action in or on the human body by
pharmacological, immunological or
metabolic means, but which may be
assisted in its function by such means;
Dose the POPE know he should register the
rythm method as a medical device
9.
10. DSCN 14/2009
Application of Patient Safety Risk
Management to the Manufacture of Health
Software
11. ISB 0129
Health Informatics — Application of clinical
risk management to the manufacture of
health software
(formerly ISO/TS 29321:2008(E))
DSCN14/2009
DSCN18/2009
12. Safety Risk analysis
If the manufacturer can provide information
showing that a safe design has been
established for a number of years and that
the product has been performing as
intended during that time such information
is likely to be sufficient to cover this
requirement
13. Modules
Some stand alone software may break down
into a significant number of applications for
the user where each of these applications
is correlated with a module.
Some of these modules may have a medical
purpose.
This raises the issue as to whether the whole product can be CE marked when not all applications have a medical purpose
It is the obligation of the manufacturer to identify the boundaries and the interfaces of the different modules/applications.
SOS intended for use in combination with other modules of the whole software structure, other devices or equipment, the whole
combination, including the connection system, must be safe and must not impair the specified performances of the modules
which are subject to the medical device Directives.
14. POST MARKET SURVEILLANCE
The Directive seeks to improve the protection of health and
safety of patients, by reducing the likelihood of similar
incidents being repeated. Consequently, the Regulations
require the manufacturer to immediately notify the Competent
Authority if the product has been involved in an incident:
Led to a death;
A serious injury or serious deterioration in the state of health
That might have led to death, serious injury
15. DECLARATION OF CONFORMITY
EC DECLARATION OF CONFORMITY
(Full quality assurance system)
The manufacturer must ensure application of
the quality system approved for the design,
manufacture and final inspection of the
products concerned, as specified in Section
3 and is subject to audit as laid down in
Sections 3.3 and 4 and to Community
surveillance as specified in Section 5.
16. What is a medical device
Any complex algorithm upon which a
clinician may rely on where the calculation
is not apparent to the clinician.
The software used for the Pandemic flu
line has been classified as a medical
device because it lead to patients receiving
(or not) a medication.
CVS risk scope is almost certainly the
same category.
17. Decision Support Software
Computer based tools which combines
medical knowledge databases and
algorithms with patient specific data.
They are intended to provide healthcare
professionals and/or users with
recommendations for or information on
diagnosis, prognosis, monitoring and
treatment of individual patients.
18. Active device for diagnosis:
Any active medical device, whether used
alone or in combination with other medical
devices, to supply information for detecting,
diagnosing, monitoring or treating
physiological conditions, states of health,
illnesses or congenital deformities.
19. Drug dosing systems
To calculate the drug dosage to be
administered to a specific patient and
therefore are qualified as medical devices.
This would include drug doses filter by age
sex gender indication.
20. Expert function software:
software which is able to analyse existing
information to generate new specific
information according to the intended use
of the software.
21. Intended purpose:
the use for which the device is intended
according to the data supplied by the
manufacturer on the labelling, in the
instructions and/or in promotional materials.
22. Placing on the market:
the first making available in return for
payment or free of charge of a device
other than a device intended for clinical
investigation, with a view to distribution
and/or use on the Community market,
regardless of whether it is new or fully
refurbished.
23. Summary
If an APP influences a Clinician and
probably also a Patient that results in
subsequent therapy you should seriously
consider if it is covered by the MDD and
seek expert guidance
Clinical safety and quality management
systems together with post marketing
survelance are critical to the process.
24. Questions
Neill.jones@nhs.net
MDD At MHRA
Full Directive
25. www.handihealth.org
info@handihealth.org
Handi Health Community Interest Company - limited by guarantee registered in England number 07999302
Registered Office: The Oakley, Kidderminster Rd, Droitwich, Worcestershire. WR9 9AY
Correspondence address: PO Box 5309 Leamington Spa, CV31 9GT