Michael D’Agosto is Professor and Dean of Studies M.Sc. Medical Devices - Regulatory Affairs at Hochschule Furtwangen University. He is a medical doctor (MD) and medical engineer by training and worked in the medical device industry prior to his academic career. Michael is also Scientific Expert and Partner at Escentia GmbH.  Michael has been part of Edvance MedTech from the very beginning, sharing his expertise and experience. He is essential for our progression with his ability to explain complex issues in a comprehensible way and for his openness to support everyone. 

Cécile van der Heijden is an attorney-at-law at Axon Lawyers and strategist in European life sciences regulation, with expertise spanning MedTech, AI, data, biotech and health law. Her special interest lies with cross-legislation and FemTech. Recognised for her cross-legislation expertise, she brings coherence to complex regulatory frameworks. She is a frequent speaker at international conferences and has published on medical devices, data governance, and health law, as well as on history, combining professional practice with academic inquiry. 

Elisabeth Oltmanns is a PhD student and her research focuses on the integration of clinical and non-clinical data (eclipse-md.com). With a background in Biomedical Engineering and an MSc in Regulatory Affairs, she combines technical expertise with regulatory insight. Alongside her academic work, she consults through Escentia, a boutique clinical affairs consultancy supporting medium-risk medical devices. Passionate about advancing medical device development, she is dedicated to transforming clinical evaluations from a regulatory requirement into a strategic advantage. 

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 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.

Marcus is a Post Market Survey expert with over seven years of experience in real-world evidence generation for the medical device and IVD industries. He joined Purdie Pascoe in 2015 after completing a First Class MSci in Natural Sciences (Chemistry with Pharmacology) at the University of Bath.
After nearly five years in primary market research, Markus transitioned into leading the Post Market Survey team in 2019. In this role, he has grown the team to 15+ specialists and overseen the delivery of more than 500 surveys across PMCF (EU-MDR), PMPF (EU-IVDR), and broader real-world data programs. His work spans a wide range of device types, including both general (Level 8) and case-specific (Level 4) surveys, many of which have been approved by leading Notified Bodies.

Nona Heueis is a microbiologist with a Phd focusing on RNA biology and antibiotic producing bacteria. Leaving academia behind and re-orienting towards industry came easy but scientific focus and love for evidence-based work stayed with her. She accompanied the (mindset) transition into MDR and navigates global strategy for medical devices in orthopedy and trauma with her growing team.

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.

With over 35 years of experience within the medical device and in-vitro diagnostic industry, Ms.Danielle Giroud is founder of MD-Clinicals (https://www.md-clinicals.com), a purely medical deviceand in-vitro diagnostic-focused CRO with offices in Switzerland, Frankfurt, and Beijing.
Ms. Giroud is regarded as an internationally recognized clinical research and regulatory expert, havingshared her extensive knowledge and experience with hundreds of multi-national companies,organizations, and start-ups from around the globe to help bring their products to market quickly andefficiently.
She is also known for her contribution and engagement as founder and senior faculty board memberof the World Medical Device Organization (https://www.wmdo.org) and is a recognised subject matterexpert providing extensive training around the world.
Since 1998, she has been extensively involved in ISO work and became in 2008 the convener for theexpert group on clinical investigations (TC 194 WG4) for the ISO 14155 and 18969 on clinicalevaluation.
From her position as a convenor of the TC 194 WG 4 she is a firm believer in regulatory convergenceand established the liaison with the EU Commission - Clinical Investigation and Evaluation (CIE) taskforce and other regulatory authorities throughout the world.

Ruth Zeller-Adam is a Senior Clinical Affairs Manager at KARL STORZ. She brings over 14 years of hands-on experience in clinical evaluation and post-market clinical follow-up. Throughout her career, she has supported Class I to Class III medical devices across their entire product lifecycle, with a strong focus on developing clinical and regulatory strategies that are both compliant and practical.

After many years as a partner at Wachenhausen Dienemann Rechtsanwälte, Susanna Dienemann has been leading the firm under her own name since April 2026. She focuses her practice on matters relating to clinical research, in particular, questions concerning contractual arrangements. She also advises clients on regulatory matters both concerning medicinal products and medical devices. In addition, she assists clients in advertising medicinal products and medical devices and anti-corruption compliance in the healthcare sector.

Ms Dienemann gained significant in-house experience during two secondments to the legal department of the Pharmaceuticals Division of Bayer AG (former: Bayer Pharma AG). Prior to joining Dienemann Rechtsanwälte she worked for the pharmaceuticals, medical devices and foods practice group at Arnold & Porter Kaye Scholer LLP’s (former: Arnold & Porter (UK) LLP) London office.

Ms Dienemann studied at the Ludwig Maximilian University of Munich and at Trinity College Dublin.

She regularly publishes articles on issues relating to pharmaceutical and medical devices law and is an experienced speaker at professional events and in-house trainings. Additionally, Ms Dienemann is a member of the "Legal Affairs" and "Admissions" committees of the German Pharmaceutical Industry Association (BPI).

Moreover, she has been a lecturer in the programme “Master of Pharma Business Administration” at the Goethe University Frankfurt/Main since 2017 and has been an honorary member of the Ethics Committee of the University of Lübeck since 2022.