RAPS UK LNG: What's Next for Regulating AI in Medical Devices?

Lena Cordie-Bancroft has over 20 years of quality and project management experience including:

• 10 years in project management at Target Financial Services;
• 11 years as Direct of Operations at Key Surgical;
• 4+ years as President, Consultant at Qualitas Professional Services.

As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on training and helping companies implement quality management systems, UDI solutions for labelling and GUDID submissions, and providing internal audit, validation, documentation and project management resources to medical device companies.

She is an active member of:

• AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the AAMI ST/WG 5 - Terminology committee
• ISO (International Organization for Standardization) – serves as a US expert on the following committees:
  • ISO/TC 198 WG 5 – Terminology
  • ISO/TC 198 WG 11 - General criteria for sterilization processes and sterilizing equipment o ISO/TC 198 WG 12 – Information for reprocessing of resterilizable devices
  • ISO/TC 210 WG 1 – Application of quality systems to medical devices
  • ISO/TC 210 WG 2 – General aspects stemming from the application of quality principles to medical devices
  • ISO/TC 210 WG 3 – Symbols and nomenclature for medical devices
• RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter and as a member of the RAPS European Council (REC)
• Member of ASQ (American Society for Quality)

Coenraad Davidsdochter is a Senior Consultant Software and Artificial Intelligence. With over 20 years of experience in software development of which over 10 years in setting-up, maintaining and improving Quality Management Systems (QMS) based on ISO 13485, MDD 93/42/EEC, MDR 2017/745 and GDPR 2016/679.

Rob Turpin is the the Head of Sector for Healthcare at the British Standards Institution (BSI), the UK's National Standards Body.

Coenraad Davidsdochter is a Senior Consultant Software and Artificial Intelligence. With over 20 years of experience in software development of which over 10 years in setting-up, maintaining and improving Quality Management Systems (QMS) based on ISO 13485, MDD 93/42/EEC, MDR 2017/745 and GDPR 2016/679.

I am responsible for developing BSI’s growth strategy within healthcare, developing and implementing market engagement, product development and go-to-market planning, focusing on priority opportunities and policy engagement to position BSI as a partner of choice in the assigned sector.

I am responsible for leading on initiatives across BSI Knowledge Solutions, supported by a multi-disciplinary team.

Paul Lambert is the Lead Standards Development Manager at BSI Group.

Prof. Dr. Christian Johner is an expert for development and approval of medical devices that contain software or that are software. As an auditor, member of a standards committee, consultant to policy makers, trainer of notified bodies and author of several books and guidelines. His guideline on AI is used by all German notified bodies to evaluate the application of machine learning in medical device. Christian is also member of a WHO working group that develops a best practice document based on his AI guideline. Christian contributes to the advancement of the regulatory landscape. His company, the Johner Institute, provides worldwide regulatory guidance, tests medical device and provides seminars and master-study courses for medical device manufacturers. Christian Johner taught at several universities e.g. in Konstanz (Germany), St. Gallen (Switzerland), Würzburg (Germany) and at Stanford University (USA).

Dr. Tido Eger : The mission of Babylon, a UK digital health company, is to make healthcare accessible and affordable globally. This is only possible by automation and standardisation, using machine learning and artificial intelligence tools wherever possible. As the Head of Regulatory & Quality at Babylon, Tido’s team shapes and provides advice on Babylon’s approach to AI in the context of medical device regulations. In the fast-paced world of software development and AI, regulations are often seen as a burden; however, Tido aims to enable and empower the Babylon teams in their approach to AI.