YOUR PARTNER IN MEDICAL DEVICE CRO

Sarah SORREL
President and CEO

Sarah Sorrel has more than 25 years of experience in medical device clinical trials and regulatory affairs in Europe and the US.
As founder and President of MedPass International, Sarah has been a pioneer by developing the first European CRO exclusively devoted to medical devices. Leading a team of clinical research and regulatory experts, Sarah has helped over 400 companies bring novel medical devices to the EU market.
Formerly having served as part of the startup team at Technomed International (now part of Siemens), Sarah brought her experience to bear at MedPass International where she has helped numerous startups develop devices that were first in their category leading to rapid acquisition by major industry players.
A recognized expert in clinical investigations of medical devices, Sarah represented AFNOR at CEN/TC258 for the development of standard EN/ISO 14155. She is a member of RAPS and a faculty member for the Society's conferences. As President of MedPass International Ltd, Sarah is a founding member of the European Association of Authorized Representatives. Sarah, an American, holds a French Baccalaureate with honors, a B.S. in Chemistry and an M.S. from the Becton School of Engineering and Applied Science at Yale University.

Jeremy Tinkler has extensive experience of the whole range of regulatory activities associated with medical devices, gained from 20 years with the Medical Device Sector of the UK Medicines and Healthcare products Regulatory Agency (MHRA). Jeremy, who is a toxicologist by training, held the position of Principal Specialist, Biosciences and Implants at MHRA and was responsible for the technical direction of safety assessments and adverse incident investigation activities for a wide range of devices.
He has extensive experience of the regulation of medical products, including tissue engineering and other emerging technologies, drug-device combinations, wound care/closure products and cardiovascular, plastic surgery, ophthalmic, orthopaedic and other implants.
His particular areas of expertise include biocompatibility and toxicology, risk management and communication, major adverse event management, assessment of animal tissues, compliance assessment, quality assurance audit, product evaluation, research commissioning, and borderline determination. Jeremy has been active for many years in standards development on biological safety, clinical investigation, non-active cardiovascular implants and risk management.

Christophe Grenot has almost 15 years of experience in the management of medical device clinical investigations in Europe. Prior to assuming responsibility for running the Clinical Operations Department at MedPass International, Christophe led many highly successful clinical projects for startups at the forefront of technological advances in interventional cardiology. One of the clinical sites he managed in Germany successfully passed an audit by the US Food and Drug Administration. Christophe came to MedPass International 10 years ago from the Clinical Research Europe department of Cordis - Johnson & Johnson after serving at J&J Interventional Systems. He holds a degree and several post graduate degrees from the University of Paris in Public Health, Clinical Trials Methodology, Monitoring and Biostatistics.

Marie-Christine Reymond is a biostatistician with over 15 years of clinical research experience.
Prior to joining MedPass where she manages a team of data managers and biostatisticians, Marie Christine held positions in various pharmaceutical CROs. Of particular importance is her significant experience in medical device trials gained as a biostatistician at ELA Medical, the cardiac rhythm management division of the Sorin Group.
During this period, Marie-Christine contributed to the statistics in numerous publications in peer review journals including Circulation and the Journal of the American College of Cardiology.
Marie Christine holds an undergraduate degree in Mathematics and a Graduate degree in Engineering Mathematics with honors from the Technical University in Montpellier, France. She also holds a Masters degree in Research Statistics from the University of Paris.

Sylvia Germain has over 25 years experience in regulation and reimbursement of medical devices in Europe. Sylvia created the Reimbursement/Funding department at MedPass International and as Director of the Reimbursement Department, Sylvia leads a team of professionals specialized in developing reimbursement and pricing strategies and preparing reimbursement files in Europe.
An expert in the health technology assessment process used by the French authorities, Sylvia has helped numerous medical device companies successfully obtain reimbursement in France, one of the most difficult markets to access in Europe.
Prior to joining MedPass International 15 years ago, Sylvia worked for LCIE (now the French Notified Body G-MED) which she represented at the French Ministry of Health Commission for homologation of patient monitoring devices.