Clinical Affairs Conference

Covering the full medical device lifecycle, the program features expert-led agendas developed by notified bodies and industry leaders, dedicated tracks for high- and low-risk devices, and real-world case studies designed to accelerate careers, strengthen businesses, and improve lives.

Join Industry Experts in

9 – 10th
February 2027
Berlin,
Germany
KARL STORZ Visitor and Training Centre 

Master the Medical Device Lifecycle from a Clinical Perspective

Choose Your Track

Dedicated tracks for Lower-Risk and Higher-Risk & Implantable devices.

Real-World Case Studies

Apply concepts through real-world examples and regulatory scenarios included in each session.

Led by Renowned MedTech Experts

Conference Chairs and international faculty share practical insights and experience.

Meet the Renowned MedTech Experts Chairing This Event

Richard Holborow

Global Head of Clinical Compliance at BSI NotifiedBody (NL) & BSI Approved Body (UK) 

Tom Melvin

Biomedical Alliance Europe, Edvance MedTech Scientific Board

Yu Jin

MDR Clinical Expert

Adam Kleinman

Associate Director, Medical & Scientific Writing at Philips | Medical Device Regulation Expert

Conference Agenda

The conference programme is organised into two parallel tracks - for high-risk and low or medium risk devices. Participants pick the track most relevant for their work at registration.

Every topic is delivered as a structured 75-minute session beginning with a brief introduction, followed by a Notified Body perspective and three practical case presentations. This format combines regulatory insights with real-world examples, enabling participants to gain practical knowledge tailored to the challenges of their device class.

Day 1 | Tuesday 9 February 2026

10:00 - 10:15 | 15-minute Break

11:30 - 12:00 | 30-minute Break

13:15 - 14:15 | Lunch

16:00 - 16:30 | 30-minute Break

Day 2 | Wednesday 10 February 2026

09:45 - 10:15 | 30-minute Break

12:00 - 13:00 | Lunch

14:15 - 14:45 | 30-minute Break


Meet the Conference Chairs

Tom Melvin
Biomedical Alliance Europe, Edvance MedTech Scientific Board


Tom Melvin is Associate Professor of Medical Device Regulatory Science at the University of Galway. Tom is Chair of the Biomedical Alliance Regulatory Affairs Committee and a member of the European Medicines Agency Expert Panels for medical devices, the European Society of Cardiology Regulatory Affairs Committee and the National Research Ethics Committee for Medical Devices. 
Tom previously worked at Trinity College Dublin and was a senior medical officer for medical devices at the Health Products Regulatory Authority and Co-Chair of the
MDCG CIE working group.
Tom has been part of Edvance MedTech from the very beginning, contributing invaluable knowledge and insight, while also keeping the founding team grounded and focused when our ideas risked running too wild.

Richard Holborow
Global Head of Clinical Compliance at BSI NotifiedBody (NL) & BSI Approved Body (UK) 

Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU. 
Yu Jin
MDR Clinical Expert


Yu Jin is a clinical and regulatory affairs specialist with an MD and PhD in cardiology and cardiovascular epidemiology. With over 15 years of experience across clinical practice, research, the medical device industry, and regulatory sectors, Dr. Jin has developed a comprehensive understanding of both the clinical and scientific aspects of medical device development and evaluation.
Currently a consultant, her career has included leadership roles in clinical and regulatory strategy, particularly in the areas of EU MDR clinical evaluations and clinical investigations. Dr. Jin has extensive expertise in the Notified Body conformity assessment process, including Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) studies, and clinical investigations.An author of over 50 peer-reviewed scientific publications, Dr. Jin is also recognized for her deep clinical expertise in cardiovascular devices.
Adam Kleinman
Associate Director, Medical & Scientific Writing at Philips | Medical Device Regulation Expert 

Adam Kleinman is the Associate Director of Medical & Scientific Writing at Philips within the Hospital Patient Monitors business. Adam has been leading the team for 3 years and is responsible for clinical evaluations, post-market clinical follow-up, clinical investigation protocols and reports, and scientific publications. Adam has expertise handling clinical evaluations and notified body deficiency reports for devices ranging from class I to III under EU MDR during his time as a consultant at RQM+ and as a senior writer and team lead at Philips.

Secure the Early Bird pricing!
Pre-registration is open

Thank you!

Let us know of your interest and we will reach out to you first once the registration is open!