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!
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 3: Chris Seaton, Director at Medicapps
Mersey Burns - our journey to CE Mark
8:30pm: networking continues!
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.
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)