The MEDIcept team provides an integrated approach to every facet of medical regulatory and compliance consulting. We’ve successfully designed, developed, patented, conducted clinical trials and obtained regulatory approval for medical devices for companies around the world.
F. David Rothkopf, President and Lead Principal
With over 20 years of medical operations, quality assurance, and regulatory compliance experience, Dave has held managerial and director positions for SON Medical, MDCI, Johnson & Johnson Professional (Depuy), Zmed, mRad and UroMed. He has extensive knowledge of regulatory audits, software risk management, design control, sterilization and packaging validation requirements and speaks regularly about quality and regulatory issues at national industry seminars.
Todd Rhodes, Senior Consultant
Todd Rhodes has 20 years experience developing and assessing Quality Management Systems, facilitating risk evaluation processes, and writing technical file. He has performed supplier qualification audits for several of our clients and has written extensively on the implementation of risk management systems for medical devices. He received his Six Sigma Black Belt certification in 2004 and CQA and BIO Audit certifications in 2011.
Sharyn Orton PhD, Senior Consultant
Sharyn is a former FDA CBER Deputy Director at CBER and Director of Regulatory Affairs at Fenwal. She has over two dozen publications and three patents to her credit and has been principal investigator on six clinical studies. With over 30 years of regulatory, clinical, and blood application and medical device application experience, Sharyn helps guide MEDIcept clients through the regulatory submittal and compliance mazes. She has currently submitted well over 30 510(k) submissions to the FDA.
Jennifer Almy, Senior Quality Consultant
Jennifer Almy has over 15 years of experience working in medical device and combination product companies performing product design, project management, quality engineering and quality system development and maintenance. Jennifer’s expertise is in creating quality systems compliant to FDA’s Quality System Regulation and ISO 13485 for small companies. She is also proficient in the areas of corrective and preventive action, internal and supplier audits, quality engineering, design control, sterilization, and complaint handling. She has worked on Class I, II and III products including angioplasty guidewires and balloon catheters, angiogenesis drug delivery devices, biopsy devices for breast cancer and collagen markers, RF and Doppler catheters for pulmonary medicine, endoscopic surgery catheters, implantable biosensors, implantable drug delivery devices, ophthalmic devices, respiratory monitors, pain management devices, wound care, and biologics. Jennifer received her BS in mechanical engineering, with an emphasis in Biomed, from Worcester Polytechnic Institute. She is a certified Lead Internal Auditor.
Mary McNamara-Cullinane, Senior Regulatory Consultant
Mary McNamara-Cullinane has over 25 years of regulatory experience in the medical device, diagnostics and biotech industries. She has successfully authored over 150 510(k)s, multiple PMAs, two DeNovo submissions and has been responsible for several clinical trials. In addition, she has strong regulatory knowledge of global regulatory practices and registrations in Europe, Korea, and Australia having work on many technical files and CERs. Prior to coming to MEDIcept, Mary was responsible for US regulatory strategy at Intrinsic Therapeutics, VP of Regulatory and Clinical Affairs at Echo Therapeutics, Director of Regulatory Affairs at Z-Medica, and Director of Regulatory Affairs and Quality Assurance at Molecular Biometrics.
Mr. Jason Gromek, Senior Quality Consultant
Jason has over 15 years of experience with various aspects of developing and accessing Quality Management Systems, and regulatory submissions. Jason has submitted 4 orthopaetic 510(k)s. He has commercialized numerous medical devices and holds several patents in medical device design. He is a Certified Quality Engineer and has experience with FDA, ISO and Notified Body audits.