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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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Covering All Angles of Quality Assurance

Every responsible medical device manufacturer is aware that the FDA requires them to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications – a protocol known as current good manufacturing practices (CGMP). These requirements were written into the original regulation issued back in 1978, which was revised, starting in 1990, into a broader and more consistent quality system (QS) regulation that is in effect today. Of...

FDA Inspection? We Can Help You Relax.

Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do you respond to a 483 notice or worse what happens if you received a warning letter? How you perform during the inspection can make all the difference in the world between a quick resolution and a long expensive remediation program....

Validating Medical Devices

One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement for any medical device manufacturer looking to achieve regulatory agency compliance and sell their products domestically and internationally. At MEDIcept, we understand that medical device testing is a rigorous and complex process...