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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.

Sharyn Orton PhD
Senior Regulatory 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.

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.

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The Latest News

We are state-of-the-art in the validation process

US Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent as medical devices become more complex in design, functionality, and technological integration. This makes the process of medical device validation and verification even more important—not only to comply with regulations, but also to aid in the design of the highest-quality components and the production process. The desired result is better repeatability, fewer mistakes,...

MDSAP: Cybersecurity and the single audit process program

For those who may not be entirely familiar with the Medical Device Single Audit Program (MDSAP), this initiative is intended to allow auditors from MDSAP-recognized Auditing Organizations (AOs) to conduct a single audit of a medical device manufacturer’s quality management system that will satisfy the requirements of the medical device regulatory authorities participating in the MDSAP program. The countries currently participating in the program include the United States, Canada, Japan,...

Medical Device Single Audit Program: What you need to know, Pt. I

Both the medical device industry and international regulators have witnessed the growing need for a standardized, worldwide approach to auditing and monitoring medical device manufacturing. A single, comprehensive process would reduce costs and speed time to market. With that goal in mind, the International Medical Device Regulators Forum (IMDRF) began work several years ago to create a program framework that would enable the conduct of a single regulatory audit of a medical device...