Amelie Oltmanns
General Manager, Germany
Amelie Oltmanns has a background in both creative and scientific studies and worked as a Medical Writing Specialist at Escentia GmbH for several years after finishing her master’s degree.
After returning from maternity leave, she took over the role of General Manager for Edvance MedTech and helps the team with her organisational skills and focus on the important steps of founding and establishing a non-profit company.
Cécile van der Heijden
Attorney-at-law, Netherlands
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.
Cécile has been part of Edvance MedTech from the very beginning, providing sharp legal insight while also surprising us with her valuable contributions to broader strategy, content, and overall direction. She continues to prove that lawyers can do far more than just legal work.
Mariana Kroupová
Project Manager, Germany
Mariana Kroupová is a project manager. With a background in education and strategic planning, she brings structure, clarity, and momentum to everything we do. She ensures our programs are delivered on time, aligned with the latest developments, and held to high standards of quality. She is passionate about turning big ideas into practical solutions and that is what she does at Edvance.
Elisabeth Oltmanns
Clinical Expert, Germany
Elisabeth Oltmanns is a PhD student with Tom Melvin 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.
Scientific Board
Folker Spitzenberger
University of Applied Sciences Lübeck (TH Lübeck), Germany
Folker Spitzenberger is a graduate chemist and received his PhD in molecular biology from the Institute of Pharmacology at Heidelberg University. After postdoctoral work at the Medical Faculty of the University of Dresden and at Yale University (CT, USA), he worked from 2002 to 2016 in the area of assessment and implementation of quality assurance systems in the field of medical devices at the ZLG, the RKI and the German accreditation body DAkkS. With the additional qualification as a Master of Drug Regulatory Affairs, he advises international organizations such as the WHO and the EU in the field of QM/QA and Regulatory Affairs. In 2016, Folker Spitzenberger joined the University of Applied Sciences Lübeck (TH Lübeck) as Professor for Regulatory Affairs for medical devices. He also continues his work as quality assessor for DAkkS and ZLG. Folker Spitzenberger actively joins various standardization committees and is co-author of many standards in the field of quality management and biomedical engineering.
Michael D’Agosto
Hochschule Furtwangen University, Germany
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.
Tom Melvin
University of Galway, Ireland
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.