Medical Device Safety Team
Charles Rivers medical device experts offer an integrated approach to medical device studies with a commitment to scientific excellence, an appreciation of client-specific, and an understanding of regulatory considerations.
François Bergeron, M.Sc.
Director of Business Development
As a trilingual senior BD strategist and deal-maker, with over 30 years of experience in the health sector within small, medium and large companies, Francois has successfully realigned business strategies and concluded significant business partnerships on four continents.
Business Development Director
Amy Stricker-Hume has been in the preclinical CRO environment since 2001, working with innovators of medical devices and combination products from early feasibility through GLP safety and post-market assessments.
Michel Assad, PhD
Executive Orthopedics and Biomaterials Director
Dr. Michel Assad is an accomplished biomaterials scientist with over 25 years of experience in preclinical research and product development.
Gerald Poeltl, MBA
Business Development Director
Gerald is a seasoned business development professional with more than 10 years of experience in senior business development and site management roles at mid-sized and global CROs. In his role he builds the bridge between science and market for medical technologies.
Nancy Doyle is a Scientific Advisor in Medical Devices, with almost 25 years of experience in the conduct and design of studies in cartilage/bone toxicology and a variety of medical devices with a good understanding of the different related guidelines. She has authored and co-authored several publications in peer reviewed journals.
Louis-Georges Guy, PhD
Senior Director of Science
Dr. Guy established the scientific program for the preclinical evaluation of medical devices in the fields of cardiology, ENT, orthopedics, and others. As an expert in bioabsorbable scaffolds, he has authored many articles, presented for sponsors in scientific meetings, and was invited as preclinical expert at a workshop at the FDA and a biodegradable metal symposium.
Dr. Maureen O’Brien is a board-certified veterinary pathologist with training and experience in the preclinical safety assessment of medical devices and pharmaceuticals.
Scott Wilson, BS
Mr. Wilson has performed a broad range of GLP and non-GLP surgical and targeted drug delivery studies. His areas of expertise include interventional cardiology, cardiovascular device safety and efficacy testing, hemostatic materials testing, and internal medicine.
Aurore Varela, DABT, DVM, MSC
Aurore Varela has over 15 years of experience in preclinical radiology, imaging, bone biomarkers, biomechanics, and study design and conduct in musculoskeletal research and toxicology. She has co-authored several research papers in peer-reviewed scientific journals, contributed to chapters in several books related to musculoskeletal research and bone pathology, and edited a book on bone toxicology.
Lyn M. Wancket, DVM, PhD, DAVCP
Dr. Wancket joined Charles River as a Veterinary Pathologist II in late 2018. Dr. Wancket has over five years of experience in medical device pathology, with a publication focus on musculoskeletal pathology and medical device models.
Miriam is a trained quality systems professional with extensive experience in FDA and ISO quality systems requirements and an extensive background in cGMP environments for medical devices. She is a subject matter expert for industry regulations including ISO 9000/13485/14971 and the Medical Device Directive.