As a Senior Director at VCLS, Christophe is responsible for leading the Medical Device and Digital Life Science Group. The Group specializes in providing advice to manufacturers of digital health technologies and ground-breaking medical devices on the design and implementation of international regulatory strategies, from an early stage of development through to market access.
Christophe has specific expertise in anticipating the regulatory and practical challenges frequently associated with innovative systems such as breakthrough digital technologies. This expertise encompasses e-health/m-health products, drug-device combinations, and in vitro diagnostics. He is also responsible for the review and submission of regulatory applications in Europe and the US, including dossiers to support CE marking, 510(k)/DeNovo/PMA and Pre-market approval, and in leading interactions with multiple regulatory bodies (e.g. Notified Bodies and National Health Competent Authorities).
Christophe brings to the role more than 20 years of Medtech experience, having worked in both SMEs and large international firms, such as Boston Scientific. During this time, he gained significant experience in the active medical device industry, in particular in next-generation implantable stimulators for neurological diseases (pelvic nerve stimulation for incontinence and spinal nerve stimulation for chronic headache). He was also responsible for the management of international proof of concept clinical trials across Europe for a wide range of innovative therapeutic indications and advanced neuroprosthetic devices in the areas of pain management and pelvic health.
Christophe began his career in 1998 at Advanced Bionics in its auditory division, working as a clinical specialist. Whilst there, he acquired an in-depth knowledge of auditory nerve stimulation to treat profound deafness. In particular, he was responsible for assisting operating theatre staff during surgical procedures and providing expertise on related products to practitioners to support post-operative programming visits with patients.
Christophe earned his Master of Science in biomedical engineering from the University of Technology of Compiègne (UTC), France, and he holds a Bachelors degree in biomedical science from the University of Toulouse, France.
Resources by Christophe Amiel, M.Sc.
webinar
Medical Device Software Development: How to Build your EU/US Strategy
This webinar helps developers of e-health/m-health solutions to better understand the regulatory environment relevant to their digital technologies in Europe…
blog
New Guidance on Clinical Evaluation of Medical Device Software
The Medical Device Coordination Group (MDCG) recently published a new guidance entitled “Guidance on Clinical Evaluation (MDR) / Performance Evaluation…
whitepaper
Navigating the Maze of m-Health Regulation and Development
The widespread adoption of mobile and wireless technologies, including smartphones and tablets, has given rise to the growing field of…
