With over 35 years of experience within the medical device and in-vitro diagnostic industry, Ms. Danielle Giroud is founder of MD-Clinicals, a purely medical device and 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, having  shared 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 and efficiently.
She is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization and is a recognised subject matter  expert providing extensive training around the world. Since 1998, she has been extensively involved in ISO work and became in 2008 the convener for the  expert group on clinical investigations (TC 194 WG4) for the ISO 14155 and 18969 on clinical  evaluation. From her position as a convenor of the TC 194 WG 4 she is a firm believer in regulatory convergence and established the liaison with the EU Commission - Clinical Investigation and Evaluation (CIE) task
force and other regulatory authorities throughout the world.

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.

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.