Call Us Today at 508-231-8842                EMERGENCY

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 Managing Partner

David has over 25 years of professional strategic experience in the development and regulatory control of medical devices. He is the President and Founding Principal at MEDIcept Inc., established in 1996, offering innovative, trusted, and cost-effective Quality, Regulatory, and Clinical solutions to the medical device and invitro diagnostic industries.

His expertise includes technical and hands-on knowledge in a variety of regulatory, management, and quality processes. He has performed over 400 ISO 13485 and FDA-style audits in the past 15 years. David has submitted over sixty-five 510ks and PMAs and, with other MEDIcept personnel, has developed nearly 150 submissions. He has trained many medical companies and the FDA on the intricacies of Design Control, CAPA, Software Validation, Risk Management, and hazard mitigation throughout a product life cycle. David has also taught classes at RAPS, ASQ, and SQA meetings. He is also an adjunct professor at MIT advising Doctoral students in Regulatory Affairs, a mentor for MassChallenge Accelerator and NIH’s NHLBI Catalyze Program, and now advises Doctoral students at Johns Hopkins Whiting School of Engineering on Medical Device Regulatory Affairs.

In addition to being President of MEDIcept Inc., David is President of SON Medical, a medical software consulting firm, and has been instrumental in starting and selling three medical device companies. Mr. Rothkopf holds both a Bachelor and Master of Mechanical Engineering degree from Worcester Polytechnic Institute in Massachusetts and an MBA from Boston University.

Susan Reilly
Managing Partner, Vice President Quality System Services

Susan has over 25 years of medical device quality system, quality engineering, and regulatory compliance experience. She has performed hundreds of Quality Management System audits and has educated numerous medical device companies on U.S. and international standards. Her areas of expertise include QMS remediation, QMS development and implementation, CAPA programs, document management systems, and supplier management programs.

Prior to joining MEDIcept in 2019, she was Founder and President of Reilly & Associates, LLC and Director of Quality Systems at MDCI. She also held Quality positions in industry at Deknatel (Pfizer) and Burron (B. Braun) Medical.

Ms. Reilly 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.

Susan was a contributing author to “The Biomedical Quality Auditor Handbook” (ASQ) and the original editor for “The Quality System Compendium – GMP Requirements and Industry Practice” (AAMI). Ms. Reilly was also 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 multiple Biomedical Division council and committee positions since 1991, including Chair. She holds a B.S. degree in Chemical Engineering from The Pennsylvania State University.

Brian Markham
Managing Partner, Vice President Quality System Services

Brian has over 30 years of medical device and quality management systems experience. He is a seasoned FDA and ISO 13485 auditor and provides audit readiness training and consultation for his clients. His expertise includes providing quality leadership for organizations undergoing significant quality system change due to regulatory concerns, remediation, acquisition, or growth. His career began as a bench chemist developing diagnostic ELISA kits. Career experience was gained through product support, development, facility compliance, and corporate level quality assurance roles.

Prior to merging with MEDIcept in 2020, he owned and operated Quality Systems in Motion, Inc. (QSIM), providing expert consultation resources to medical device, biotech, and pharmaceutical organizations facing challenging compliance concerns. Brian has served in quality leadership positions at both small and large organizations, including Boston Scientific and Abbot BioReseach.

He holds a Bachelor’s degree in Chemistry from Virginia Tech and an Associate’s degree in Mathematics from Bergen Community College.

Jason Gromek
Partner, Sr. Director of Quality System Services and Development

Jason has over 19 years of medical device design, quality system, quality engineering, and regulatory compliance experience. Jason’s areas of expertise include design control, QMS development and implementation, project management, medical device software, CAPA programs, electronic QMS implementation and validation, FDA inspections, and remediation projects.

Jason has held various management positions, both as a consultant and in industry. Before joining MEDIcept, Jason was Founder and President of BioDevice Design, LLC, a medical device development company. BioDevice was a founding member organization of America Makes – National Additive Manufacturing Innovation Institute, which was established to promote 3D printing in manufacturing.

He was Director of Engineering and Development at Meditech Spine and worked as a medical device design consultant for O’Savage Biomechanics. While at Meditech, Jason led the initiative to obtain regulatory clearance for Hydroxy appetite PEEK. Jason holds many patents in the areas of spinal implants.

Mr. Gromek is a member of ASQ and is a Certified Biomedical Auditor and Certified Quality Auditor. Jason holds an Associate of Arts and Associate of Science degree from Lakeland Community College.

Jennifer Almy
Partner, Director of Quality System Services

Jennifer has over 20 years of medical device quality system and quality engineering experience. She has established, maintained, and remediated Quality Management Systems for numerous medical device companies ranging from Class I wound care to Class III implantables. She is passionate about developing effective and efficient quality systems in compliance with U.S. and international standards, especially scaling and tailoring the system for small and early stage companies.

Before joining MEDIcept in 2014, she held Quality Systems Director level positions at various startup companies on both the west and east coasts. Her areas of expertise include QMS development and implementation, CAPA, critical success metrics and data trending, document management, training, and supplier management programs.

Ms. Almy holds a B.S. degree in Mechanical Engineering from Worcester Polytechnic Institute, and actively volunteers as a Technical Advisor for Worcester Polytechnic Institute’s Technical Advisors Network (entrepreneurial program). She is also an officer on the New England Discussion Group for the American Society of Quality, holding officer positions since 2005.

Scott Blood
Director of Regulatory Services

Scott Blood brings over 25 years of professional experience and leadership in quality, regulatory, operations, and product design for life science companies. He is currently the Principal Quality & Regulatory Consultant at MEDIcept, Inc. Over his career, Scott has submitted approximately 100 device applications to regulatory authorities.

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 science 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. He is a frequent lecturer on quality, clinical, and regulatory topics relevant to the medical device industry.

Scott holds a B.S. degree from Wentworth Institute of Technology, and Certified Quality Auditor and Certified Quality Engineer certifications through ASQ.

L. Adelina Paunescu, Ph.D.
Vice President of Clinical Services

Adelina has 20 years of medical device and invitro diagnostic clinical operations and trial management experience. She led clinical trials globally across more than 1,400 trial centers and 10,000 patients, and she has educated medical companies on U.S. and international clinical trial standards. Her areas of expertise include pre-clinical, feasibility, first-in-man and complex global clinical trials, post-approval studies and post-market registries for enhancement of data collection, and long term safety. She has also developed numerous MDD and MDR clinical evaluation reports. In addition to medical devices, Adelina also has experience in pharmaceutical and biologics and has been involved in submissions of Investigational New Drug and Biologics License Applications.

She partnered with MEDIcept in 2019 and she is the Founder and President of ACMP Clinical and Regulatory Consulting, LLC. Her prior positions include Director of Clinical Operations at companies such as Transmedics, Heartware/Medtronic, and Reflectance Medical.

Adelina was a contributing author to the “Future of Optical Coherence Tomography: Ultrahigh-Resolution Versus Standard-Resolution OCT” and has authored over 40 peer reviewed articles and conference presentations. She also served as manuscript reviewer to 4 peer reviewed scientific journals.

Dr. Paunescu holds an M.S. degree in Physics from the University of Bucharest, Romania and a Ph.D. in Biophysics from the University of Illinois at Urbana-Champaign.

Henry R. Hidalgo
Senior Quality Consultant

Henry, a Senior Quality Consultant for MEDIcept, has over 18 years of medical device experience, including sterilization, quality systems, quality engineering, and regulatory compliance. In addition, Henry’s areas of expertise includes development and implementation of sterilization processes, technology transfer, CAPA, and software validation.

Henry has held various industry management positions. Before joining MEDIcept, Henry was a Senior Manager of QA at Vygon US, a leading medical device company in Neonatology and Enteral nutrition products, and Manager of Quality Systems at Corindus Vascular Robotics, a Siemens company. At Corindus Vascular Robotics, Henry managed the validation and implementation of Arena PLM, an electronic QMS. He also led the project to significantly enhance the EtO sterilization output to accommodate the increased customer demand by validating a six-pallet load, which used to be a one pallet load.

Before Vygon and Corindus, Mr. Hidalgo worked as a Senior Manager of Microbiology and Sterility Assurance at ConforMIS, a cutting-edge medical device company that manufactures patient-specific knee implants. While at ConforMIS, Henry led the effort to source, install, and validate a microbiology lab, along with the validation of test methods for sustaining product and clean room monitoring activities. He also led the project to convert the sterilization method from Vapor Hydrogen Peroxide to Ethylene Oxide, which was required due to an increased volume of product sales.

Mr. Hidalgo holds a Bachelor of Science degree in Biochemistry from Salem State College and has done post-graduate work in Mechanical Engineering at the University of Massachusetts-Lowell.

Katherine M. Williams, M.Ed.
Senior Quality Consultant

Katherine, a Senior Quality Consultant for MEDIcept, has over 25 years of medical device design, quality system, quality engineering, regulatory compliance, and training experience. As a former Deputy District Director, Compliance Officer, and Consumer Safety Officer for the U.S. Food and Drug Administration, Katherine’s areas of expertise include FDA inspections, 483 and warning letter remediation, QMS development and implementation, CAPA systems, and design controls.

In addition to her FDA experience, during the MDSAP pilot, Katherine was a Technical File Reviewer and CE Officer for the National Standard Authority of Ireland, Inc. (NSAI). Katherine has held various positions in the industry, including Quality Manager, Quality Engineer, R&D Engineer, Senior Quality and Compliance Manager, and Acting Head of Regulatory Affairs. Before joining MEDIcept, Katherine was Founder and President of Certified Quality Associates, Inc., a medical device consultancy.

Katherine is an ASQ Certified Quality Engineer, Certified Quality Auditor, Certified Quality Manager, and an Exemplar Global Principal Quality Auditor for ISO 9001 and ISO 13485. Katherine earned her Bachelor’s degree in Mechanical Engineering from the University of Cincinnati and her MBA from Franklin University. She also holds an eLearning certificate and Master’s in Instructional Design and Development from George Mason University.

Saba M. Shahid, M.S.
Senior Regulatory Consultant

Saba Shahid, a Senior Regulatory Affairs Consultant, brings over 10 years of regulatory experience in the medical device industry, specializing in life-cycle management on a variety of product classifications. She has held leadership positions in several previous companies, and her experience includes regulatory strategy, documentation development for products, and registration requirements, in both the North American and international markets.

Throughout her career, Saba has re-built regulatory departments through the implementation of processes and procedures for compliance and audit-readiness.

Saba is ISO 13485 Internal Audit certified and a seasoned auditee leading Notified Body, FDA, and country-specific audits. She is also a member of the Regulatory Affairs Professional Society. Saba speaks multiple languages and holds a Bachelor’s Degree in biology and a Master’s Degree in biomedical science from Quinnipiac University.

Sharyn Orton PhD
Senior Regulatory Consultant

Sharyn Orton, a Senior Regulatory Affairs Consultant at MEDIcept, 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, blood application, and medical device application experience, Sharyn helps guide MEDIcept clients through the regulatory submittal and compliance mazes. She specializes in IVD and orthopaedic submissions.

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.

Dr. Orton holds a Bachelor’s Degree in Pharmacy and Allied Health, a Master’s Degree in Public Health (Epidemiology and Biostatistics), and a Ph.D. in Epidemiology from the University of South Florida.