President and CEO
Sarah Sorrel has more than 30 years of experience of medical device regulation and clinical trials with an emphasis on emerging technologies.
She is founder and President of MedPass International, the leading European CRO and consultancy for the development and market access of new medical technologies. Following early experience gained in a French start up that went on to receive PMA approval in the US, she created MedPass 25 years ago to assemble teams of highly skilled regulatory and clinical experts that could be outsourced to start up companies enabling them to achieve their goals cost efficiently. During this time, MedPass has successfully helped over 1,000 medical device companies worldwide bring new technologies to the EU market.
Sarah is a recognized expert in EU medical device regulation and clinical investigations. She has spoken at and chaired conferences organized by RAPS and Medtec Ireland. She has written recent articles for industry trade journals. Sarah is American and holds a degree in Engineering and Applied Science from Yale University.
Non Executive Chairman
Harvey Grove, a Fellow of the Institute of Chartered Accountants with over 25 years experience in the medical device industry, Harvey has advised Medpass since 1999.
Formerly Managing Partner of a large UK accounting firm, he has extensive experience in the management and development of large corporates and currently advises the Boards of a number of UK companies with significant international operations.
He became Non Executive Chairman of Medpass in January 2011 and provides guidance on strategic development, management and finance.
Director of Reg. Affairs & Clinical Operations
Estelle Geffard is a biomedical engineer with more than 20 years of experience in medical device regulation and clinical investigations.
As Director of Regulatory Affairs and Clinical Operations at MedPass, she oversees all clinical investigation operations across the 28 EU countries involving over 50 clinical and regulatory staff working to ISO 13485 quality system.
Estelle joined MedPass after holding senior positions in major US CROs such as Quintiles. Estelle also worked at the French Competent Authority. She started her career as a field applications engineer in Cardiac Rhythm Management devices at Medtronic.
David Francis, a European Engineer, Chartered Engineer, Fellow of the Institution of Mechanical Engineers and member of the Institution of Engineering and Technology with more 35 years experience in medical devices, precision electro-mechanical engineering, aerospace, avionics and defence sectors, David joined MedPass in July 2015.
Formerly Global Head of Active Implantable Devices at BSI Notified Body, David managed a team dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers around the world. He has significant experience with high-risk implantable devices, internal radiotherapy (brachytherapy) devices and devices incorporating wireless telemetry.
He is a Technical Specialist conducting reviews of Design Dossiers / Technical Files and performing technical audits for devices as part of the CE marking approval process for Europe. Technical reviews involve a review of compliance with the essential requirements of the Medical Devices Directives, including verification & validation testing, risk management, clinical evaluation, post market surveillance, technical standards, packaging integrity & transit testing, product lifetime, shelf-life, and software life cycle processes.
Director of Regulatory Consultancy
Jeremy Tinkler has 27 years experience in regulatory activities associated with medical devices, of which 20 were with 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.
Dr Simon St CLAIR CARTER
Dr. Simon St Clair Carter trained as a Urological Surgeon at University College, Westminster Medical School, the Institute of Urology in London and Baylor University in Houston USA. He worked as a consultant at Imperial College Hospitals until 2012 when he became Medical Director of the London Clinic, the largest private Hospital in the UK. His research has been in the development of novel treatment for prostate disease and bladder dysfunction. He developed the research programme for Microwave treatment for BPH and successful presentation to the FDA panel. Subsequently has researched the physiological measurement of bladder function. While at the London Clinic he ran the Advanced Treatment Centre, a small research facility with a varied portfolio of device and drug projects. He now joins the team at Medpass to give clinical advice on device development.
Director of Data Management & Biostatistics
Marie-Christine Reymond is a biostatistician with over 20 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.
Deputy Director of Clinical Operations
Chantal Cassiram has 24 years experience in the management of medical device and drug clinical trials in Europe.
She holds a M.S in Biology from Lille University and a Business Degree. She started her career as a Clinical Research Associate in Rhone Poulenc Rorer (now Sanofi) and SmithKline Beecham (now part of GSK).
She joined Medtronic in 1995 as a Clinical Field Specialist and subsequently became a Clinical Project Manager for the CardioVascular Business Unit. She furthered her clinical experience when spending four years in companies specialized in medical imaging and biotechnologies. Chantal joined MedPass in 2006 as a Senior Project Manager and led a number of highly successful clinical projects for start-ups at the forefront of technological advances in cardiology.
She became Deputy Director of the Clinical Operations in July 2011.
Calixte de BAUDUS
New Business Development Manager
Calixte de Baudus joined MedPass in 2012 after graduating from his Master Degree in Applied Business from ISG Paris and was subsequently promoted to Manager, Business Development to manage global business development strategy and execution for Clinical Research. Calixte works closely with the directors developing new market opportunities, responding to requests for proposals and supervises contract negotiations and client care.
QA and HR Manager
Julie Delrue, an English Language graduate from the University of Valenciennes joined the Clinical Operations Department of MedPass in 2006.
After joining our clinical operations department she was rapidly promoted to senior assistant in the Regulatory Affairs department with responsibility for Authorised Representative services and our Adverse Event Surveillance Unit. Julie has extensive experience of the medical device industry and the essential requirements for successful trial outcomes.
Julie is now Q.A. and HR Manager and is responsible for the management and maintenance of our Quality Assurance System.
Regulatory Affairs Manager
Armêl Plaine, holds a MSc in Biology from Düsseldorf University and a PhD in microbiology from AgroParisTech in Paris. She has more than ten years experience in the medical device industry and has enjoyed a leading role in major medical device trials across a wide range of therapeutic areas.
After initially joining the MedPass Clinical Operations team she moved to the Regulatory Affairs Department and became Manager of Regulatory Affairs in 2017.