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Team

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 almost 30 years of medical operations, quality assurance, and regulatory compliance experience, David has held managerial and director positions for Johnson & Johnson Professional (Depuy), Zmed, mRad, SON Medical, MDCI, and UroMed. He has extensive knowledge of regulatory audits, software risk management, design control, sterilization and packaging validation requirements. David has performed over 450: ISO 13485, MDD and FDA-style audits. He is a Senior Member of ASQ and RAPS and has held numerous ASQ Biomedical Division council and committee positions. David teaches post-doctoral student classes on Regulatory Affairs at the MIT/Harvard LinQ and Idea2 programs. He speaks regularly about quality and regulatory issues at internationals and national industry seminars. David holds both a Bachelor and Master of Mechanical Engineering degree from WPI in Massachusetts and an MBA from Boston University.

Sharyn Orton PhD
Senior Regulatory Consultant

Sharyn is a former FDA Deputy Director at CBER where she managed and oversaw regulatory submissions and helped make regulatory policy. 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 over two dozen publications and three patents to her credit and has been principal investigator on six clinical studies. She has currently submitted well over forty 510(k) submissions, IDE, and BLA to the FDA and over twenty Clinical Evaluation Reports, and Technical Files to multiple notified bodies.

Susan Reilly
Principal and Partner

With over 30 years of medical device quality management system, quality engineering, and regulatory compliance experience, Susan has a proven track record in providing clients cost effective solutions for achieving their quality goals and conforming with FDA regulations, EU requirements, Canadian and Australian medical device regulations, and ISO Standards. She has held leadership positions in Quality at MDCI, Deknatel. (Pfizer), and Burron Medical (B. Braun). In addition, Susan has served as an expert witness on behalf of FDA and was an active participant in the FDA/Medical Device Industry Initiative Task Force.  She was a member of the Advisory Committee for the ASQ CQA – Biomedical Certification and a past member of the AdvaMed QA Committee. She is a contributing author to “The Biomedical Quality Auditor Handbook” (ASQ), the original editor for “The Quality System Compendium – GMP Requirements and Industry Practice” (AAMI), and a contributor to the AdvaMed “Points to Consider When Preparing for a QSIT Inspection” documents.  She is a Senior Member of ASQ and has held numerous Biomedical Division council and committee positions since 1991, including Chair.  She holds a B.S. degree in Chemical Engineering from The Pennsylvania State University.

Scott Blood
Principal Quality and Regulatory Consultant

Scott Blood brings more than 25 years of professional experience and leadership in quality, regulatory, operations, and product design for life sciences companies. Scott has held leadership positions in Quality, Regulatory, and Operations at Solace Therapeutics, NinePoint Medical, Candela Corporation, InfraReDx, Inc., Fossa Medical, and PercuSurge, Inc as well as providing consulting services to several other life sciences companies. Scott is the Past Chair of the Biomedical Division of the American Society of Quality (ASQ), a former member of the Board of Directors of the Massachusetts Medical Device Industry Council (MassMEDIC), and a member of the Regulatory Affairs Professionals Society, as well as a frequent lecturer on quality, clinical and regulatory topics relevant to the medical device industry. Scott holds a BS degree from Wentworth Institute of Technology, as well as CQE and CQA certification through ASQ and RAC-US through RAPS.

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. 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 several 510(k)s. He has commercialized numerous medical devices and holds several patents in medical device design. He is a Certified Quality Engineer, Certified Biomedical Auditor, and a certified ISO13485 Lead Internal Auditor.

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The Latest News

FDA Updates Special 510(k) Guidance

FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket Approval (PMA) process. In September 2019, a modified version of this program was published to create a streamlined review of technological changes made to a manufacturer’s own cleared device which leveraged design control requirements....

Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting

The Immunology Devices Panel of the FDA’s Medical Device Advisory Committee met in November to discuss the topic of immunological responses to metal-containing products regulated as medical devices. The panel focused on metal-containing implants as well as dental amalgam. Recent post-market issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological...

Quality Systems in Motion, Inc. (QSIM) is now part of MEDIcept Inc.

For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies. QSIM, under the direction of Brian Markham, President, specialized in providing leadership and resources for organizations undergoing significant quality system change due to...