Regulatory requirements for mHealth apps (CE Mark, FDA)

  • March 27, 2014 · 6:30 PM
  • Greenheys Building, Manchester Science Park

This time we will explore how if and how regulatory requirements can add value to mHealth apps. 

We will as well provide you with an overview of US & EU regulations and local health care providers requirements including practical examples of how they are applied. 

This is a unique opportunity for anyone developing or thinking about developing apps or apps/device combinations for health care markets to hear from experts and practitioners in that area and to acquire some very useful knowledge and understanding.  So come along and get that edge over your competitors!

Really looking forward to inspiring talks and discussion!


Agenda

6:30pm networking

7pm Talk 1:  Dr. Antony Rix, Senior Consultant in Communications and Wireless at TTP and a member of American Telemedicine Association (ATA)

"Medical device developer perspective: pathways to approval for apps and app/device combinations"

• Case studies of mHealth apps - regulated and unregulated

• Medical devices combined with an app and data platform

• Introduction to FDA requirements

• Comparison of US & European regulations

• Future trends in regulation


7:40pm Talk 2:  Andrew Stopford, Technical Director at Havas Lynx

"SO 62304 & TIR45 – Medical Devices and Software Engineering"

This talk will look at ISO 62304, the key standard for Software Engineering and Medical Devices. It will then look at TIR 45, the FDA approved guidance on applying agile practices to both ISO 62304 and the key requirements of the FDA.

8:10pm Talk 3Chris Seaton, Director at Medicapps

Mersey Burns - our journey to CE Mark


8:30pm: networking continues!


BIOs

Dr. Antony Rix is a Senior Consultant in the Communications and Wireless group at TTP, Europe's leading independent technology consultancy and product development company.  He has led projects in areas including mobile TV, phone apps, network planning, and novel short-range and wide area wireless technologies.  Antony is currently engaged in business development, programme management and regulatory planning in wireless healthcare, mHealth and in safety-related radio systems.

Before he joined TTP in 2004, Antony worked at BT’s Research Laboratories and then co-founded Psytechnics, a successful start-up company developing quality of service and network monitoring software.

Antony has a Ph.D. from the University of Edinburgh and a Masters in Engineering from the University of Cambridge.  He is a member of the American Telemedicine Association, Institute of Engineering and Technology and Audio Engineering Society, and he co-chairs the Cambridge Wireless Special Interest Group on Connected Devices. For more information please visit www.ttp.com


Andrew Stopford is a Technical Director @ Havas Lynx and has over 16 years experience leading teams to deliver pioneering software solutions that enable business goals to be achieved. With experience drawn from the e-commerce, financial, insurance, banking and healthcare sectors he is committed to creating quality software that adheres to best practices and delivers solutions that are robust and help clients achieve business goals.

Andy is a software engineer by trade and is a published book author and keen writer with 200 magazine and journal articles over his career. He has a great depth and breadth of knowledge in a variety of technologies and is passionate about all things software engineering.

Andy is responsible for driving the adoption of ISO 13485 within Havas Lynx and is a trained ISO 13485 auditor.


Chris Seaton 

I am a PhD student at the University of Manchester, where I am researching programming languages and irregular parallelism. I am also a member of the Virtual Machine research group at Oracle Labs, where I work on implementing programming languages using the next generation of Java Virtual Machine.

In my spare time I develop an award winning medical app that is the first app regulated as a medical device in the UK, and run a consultancy to help clients such as the NHS to develop revolutionary medical software.

Between my undergraduate degree and starting my PhD I commissioned as an officer in the British Army, first in the regulars and now in the reserves. I've led both on operations and in training units in the UK and around the world. (http://www.chrisseaton.com)



Join or login to comment.

  • Tony K.

    Great but always better when people talk about real examples like Chris and Antony did

    March 29, 2014

  • Amir R.

    I'm sorry that I was unable to stay and network after the meeting. The meeting itself was highly relevant to what we are trying to achieve at the Childhood Arthritis Prospective Study (CAPS) with our app designed to capture a child's experience of pain. We have the preliminary iterations of the app and are testing and developing it incrementally. So as I say these talks were highly informative to our potential future plans. Many thanks to everyone involved in the organisation of the meeting and also to the speakers as well.

    March 27, 2014

  • Amir R.

    Very informative and relevant to my work

    March 27, 2014

  • Eva B.

    I apologize for the late notice of declining, however I am unable to travel to Manchester today due to some personal issues. I really wanted to meet some of you, as I am a newby in the field, however will have to postpone it for next time. Hope you have a great event.

    March 27, 2014

  • Mark D.

    Hope it goes well and now need to watch my kids as wife going out! Questions: do we need to quality assure apps? What role does the NHS Apps Library play in all this? When does lifestyle monitoring become medical given it has more of an influence on health outcomes than medicine(s) itself?

    March 27, 2014

    • Dan L.

      Mark love the lifestyle question. Not sure it was ever divorced from medical but you are onto THE challenge which is what are the KPIs for lifestyle and I'm talking 'personal' too? Know these and its a game changer.

      March 27, 2014

    • Idalia D.

      Isn't that assuming that people will actually want to change their lifestyles…?

      March 27, 2014

  • Lisa D.

    Free mHealth report. At the end of last year, we conducted independent research into how people really use health and wellbeing apps. It's really insightful and people's distrust of health apps and the need for regulation was incredibly apparent in the results. We've just launched this as a free report. If you'd like a copy just catch me at the event or email [masked]

    1 · March 25, 2014

    • Lisa D.

      No problem Idalia - just sent you a copy.

      March 25, 2014

    • Philip V.

      A useful piece of research. Many thanks Lisa.

      March 27, 2014

  • Idalia D.

    mHealth apps dilemma: to be or not to be [a medical device]? Join the conversation: http://linkd.in/1gVZZC0

    March 25, 2014

  • Julie A.

    Thanks Lisa - I'll email to request a copy.

    March 25, 2014

  • Amrik M.

    Unfortunately can't make this one - agenda looks good

    March 23, 2014

  • Christopher H.

    Just realized I can't go on Thursday.

    March 21, 2014

  • Christopher H.

    Excellent presentation from FDA CDRH staffers today at mct-congress Edinburgh. 'BYOD is on' is how Jeff Lee summarised #MCTCongress

    March 21, 2014

  • Idalia D.

    New MHRA guidance on this subject (published yesterday): http://bit.ly/1d31Bif

    1 · March 20, 2014

  • Howard L.

    Sorry, won't be able to make this Meetup. I'm not too clear how the prescribing apps issue applies in the NHS. In my experience the app and the attendant data is usially a patient initiative. What does cause a problem is what to do with this data. How useful is it to clinicians and how does it relate to their EMR?!

    March 20, 2014

  • A former member
    A former member

    I have some projects that hopefully are achievable in the medical section! Currently working towards submitting ideas for Intel competition. Was wondering I could may be share some of those ideas and see where things go!

    March 15, 2014

  • Idalia D.

    According to recent poll 42% doctors won't prescribe apps 4 lack of regulatory oversight of them http://bit.ly/1gPaLLX

    This is a clear indication of commercial as well as patient safety related value in regulating mHealth. On the other hand you have US Senate Protect Act bill bit.ly/NRUfm6 So where is the right balance and what can entrepreneurs do now? Come and join the debate :)

    3 · March 5, 2014

  • Idalia D.

    We are now working on the agenda for this event. What specific questions would you seek answers too?
    Are there any particular areas of this subject you are interested in? Thanks!

    February 21, 2014

  • Christopher H.

    Just browsing on some examples to illustrate the scope of 'digital health & mobile health' and I found a tale of someone encountering the demanding world of regulated product development. It's worth noting that for devices, the EU and USA have different approaches. That the regulations are there to help is sometimes missed if you're not prepared for them. http://www.diabetesmine.com/2010/08/insulin-pump-manufacter-is-complicated-but-making-iphone-strides.html

    1 · February 19, 2014

  • Pierre-Antoine

    I must apologise as I can no longer attend this event. I was planning on attending after work in Huddersfield, but I now have a to be in London that afternoon finishing at 5.

    So sorry. I was looking forward to this. I'll keep watching for other events.

    January 9, 2014

  • Pierre-Antoine

    This is an important topic that often gets ignored. I would be interested in hearing how others have addressed these issues (ISB0129 in particular) and share the experience of our group in Yorkshire. Any ideas for a date? Sometime after April would be good for me. ;)

    January 2, 2014

    • Pierre-Antoine

      We studied the European Commission flowchart from MEDDEV 2.1/6 (the same that the MHRA reference) at the technical specs writing phase of the project to ensure that Ignaz Handbook is not a medical device.

      January 6, 2014

    • Pierre-Antoine

      The suggested date might work. I'll do everything I can to make it work. Do you usually meet somewhere central near the train stations? or peripheral?

      January 6, 2014

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