Medical Devices & Combination Products
Christophe Amiel is heading the design and implementation of regulatory strategy as Senior Director within Voisin Consulting Life Sciences for medical devices (including in vitro diagnostics), e-health products, as well as combination products (drug-device association) including activities related to Clinical Trials Application and vigilance.
Christophe has significant experience in clinical programs design and implementation, including their regulatory set-up and management from the clinical trial application (CTA) to the submission of the clinical study report. Based on his 20 years’ medtech experience and conducting global regulatory strategic analyses from early development phases to market access, Christophe focuses on the anticipation of regulatory and practical challenges associated with innovative systems such as e-health technologies. He leads the preparation of regulatory strategy, the submission of regulatory applications in Europe and the US, the interaction with regulatory bodies (Notified Bodies and national health Competent Authorities), the preparation of risk management plan and the support of Pre- and Post-market medical device vigilance activities and reporting. His expertise with regulatory market clearances primarily encompasses CE marking, 510(k) and Pre-market approval dossiers.
Prior to joining VCLS, Christophe served since 2001 as Manager for clinical operations at Advanced Bionics in its emerging indications department where he gained significant experience in the active medical device industry, and more specifically on next-generation implantable stimulators for neurological diseases. He developed a particular expertise in pelvic nerve stimulation for incontinence and spinal nerve stimulation for chronic headache.
Christophe was 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. As a Project Manager, he led the preparation of CTAs, including the writing and review of the study core documents (protocol, Investigator’s Brochure, etc.), and the preparation of all subsequent applications (e.g. amendments), for submission to both Competent Authorities and Ethics Committees. Christophe developed a solid technical expertise in clinical trial regulations and associated country-specific requirements.
Christophe began his career in 1998 at Advanced Bionics as a field clinical specialist in its auditory division for Southern Europe and Middle East regions and thus acquired an in-depth knowledge about auditory nerve stimulation for profound deafness. He was specifically in charge of assisting operating theatre department staffs during surgical procedures and providing products expertise to practitioners on post-operative programming visits with the patients.
Christophe earned his Master of Science in biomedical engineering at the University of Technology of Compiègne (UTC), France. He previously received his Bachelor degree in biomedical science from the University of Toulouse, France. He is based in Paris, France.