MEDIcept is an international medical device and IVD compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, and Clinical services. Our experienced team of former FDA, ISO, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial to meet your specific needs.
MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions.
F. David Rothkopf - President and Founding 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 an adjunct professor at MIT advising Doctoral students in Regulatory Affairs, a mentor for MassChallenge Accelerator and NIH’s NHLBI Catalyze Program, and 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. He has been instrumental in starting and selling three medical device companies. Mr. Rothkopf holds a Bachelor’s and Master’s of Mechanical Engineering degree from Worcester Polytechnic Institute in Massachusetts and an MBA from Boston 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 small and large organizations, including Boston Scientific and Abbot BioReseach.
He holds a Bachelor’s of Science degree in Chemistry from Virginia Tech and an Associate’s degree in Mathematics from Bergen Community College.
Susan Reilly, Managing Partner
Susan has over 30 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.
Before 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 Bachelor’s of Science degree in Chemical Engineering from The Pennsylvania State University.
L. Adelina Paunescu, Ph.D. - Managing Partner, Vice President of Clinical Services
Adelina has 20 years of medical device and invitro diagnostic clinical operations and trial management experience in various therapeutic areas. She led clinical trials globally across more than 1,400 trial centers and over 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 expertise with IDE, PMA, and 510(k) submissions for all Class devices and IVDs. She 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 Investigational New Drug and Biologics License Applications submissions.
Before joining MEDIcept, she was the Founder and President of ACMP Clinical and Regulatory Consulting, LLC since 2017 and collaborated with MEDIcept since 2019. Her prior positions include Director of Clinical Operations at 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 four peer reviewed scientific journals.
Dr. Paunescu holds a Masters degree in Physics from the University of Bucharest, Romania, and a Ph.D. in Biophysics from the University of Illinois at Urbana-Champaign.
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 expertise includes 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, regulatory compliance, CAPA, critical success metrics and data trending, document management, training, and supplier management programs.
Ms. Almy holds a Bachelor’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. 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 Bachelor’s degree from Wentworth Institute of Technology and Certified Quality Auditor and Certified Quality Engineer certifications through ASQ.
Dawn Ross, Director of Staff Development and Training
Dawn brings more than 25 years of medical device experience to MEDIcept. Her main area of expertise is risk-based, lean QMS establishment and remediation. Dawn has successfully managed various large and small complex, technical projects, and staff development throughout her career.
Her medical device industry experience includes working with fully automated, electro-mechanical medical devices within the clinical disciplines of cardiovascular open heart surgical products, kidney dialysis, clinical chemistry and assay testing, point of care patient monitoring products, computer and data information systems, orthopedic implants and coatings, chemistry reagents, medical device accessories, and sterile and non-sterile packaging.
Before joining MEDIcept, Dawn served as Vice President of Quality with a small IVD startup company where she successfully established and trained the organization on the Regulatory, Clinical, and QMS. She contributed to the company’s successful marketing of its (IVD) xPCR laboratory testing platform, 13 related assays, and its acquisition.
With a clinical laboratory background (clinical laboratory, infection controls, quality and risk depts, infection control, and electronic medical records/IT), Dawn is proficient in Good Laboratory Practices, CLIA, COLA, JCHAO, and the other medical device GxP disciplines.
As an experienced certified auditor, Dawn has an in-depth knowledge of FDA, Regulatory, Clinical, and ISO requirements pertaining to product submissions, product development, risk management, and post-market activities. Dawn has additional skills and practical application in project management, lean process development, six sigma principles, leadership courses, organizational alignment, and adult training.
Dawn holds a Bachelor’s of Science in Health Care Administration/Project Management from Ferris State and is certified as a Medical Laboratory Technician by the American Society for Clinical Pathology (ASCP).
Jerika Acosta, Director of Clinical Operations
Jerika Acosta joins MEDIcept with over 17 years of industry leadership and management experience in Phase I-IV pharmaceutical and device clinical trials. She has worked in CRO, pharma, and academic environments, including operational oversight of multi-therapeutic global programs leading to successful regulatory submissions and product launches for multiple leading organizations.
Using her scientific training and industry knowledge to support various projects in clinical development, safety, medical writing, and regulatory, Jerika has designed, managed, and executed a large number of clinical trials worldwide.
She has managed multi-compound portfolios inclusive of adult and pediatric trials in large programs. Jerika’s background includes Clinical Development, Program Management, Strategic Planning, Risk Management, and Process Excellence.
Her experience spans across a variety of therapeutic areas, including, but not limited to, Oncology (Pediatric AML, Metastatic Pancreatic Adenocarcinoma, Gynecology), Infectious Diseases (COVID-19, Hepatitis), and Neurology (Pain, Pediatric Epilepsy, Neurological Trauma).
As Director of Clinical Operations, Jerika’s responsibilities include providing leadership and support to all Clinical Operation team members while effectively motivating others to succeed with her strong drive to achieve results.
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 include developing and implementing 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’s of Science degree in Biochemistry from Salem State College and has done post-graduate work in Mechanical Engineering at the University of Massachusetts-Lowell.
Natalie Vollrath, Senior Regulatory Consultant
Natalie Vollrath brings over 30 years of experience as a quality and regulatory professional in the medical device industry. She has broad experience across multiple product categories and device classes, preparing regulatory submissions and obtaining product registrations for U.S. and international markets. Natalie has led ISO and FDA regulatory and compliance efforts throughout the product lifecycle and played a key role in new product introductions.
Natalie is a member of the Association for the Advancement of Medical Instrumentation (AAMI) and the American Society for Quality (ASQ). She has served in various positions on the boards of local ASQ sections for many years.
Natalie holds a BA degree from the University of California, San Diego, and certificates in Systems Engineering and Biostatistics. She is Regulatory Affairs Certified through the Regulatory Affairs Professionals Society (RAPS). Natalie also holds several additional certifications through ASQ, including Certified Medical Device Auditor and Certified Software Quality Engineer.
Stephen Gilbert, Senior Quality Engineering Consultant
Stephen is a mechanical engineer with over 30 years of experience in the medical device industry (orthopedics, radiation therapy, intraoperative x-ray, and laser therapy). His main areas of expertise are in the Product Development Process and Project Management within the regulatory requirements of QS Reg, MDD, MDR, ISO 13485, and GxP.
Before joining MEDIcept, he was a consultant partner for Wipro, where his main efforts were in helping companies meet MDR requirements. This included performing gap analyses and remediation of QMS and product Design History Files for domestic and international clients. He also held positions in Product Development at Stryker, Depuy-Synthes, and Zimmer.
Stephen has extensive experience in design control, risk management, CAPA, complaint handling, change management, and product verification and validation, including fatigue testing, fracture analysis, FEA, cadaver sessions, competitive benchmarking, and reverse engineering. He has authored or contributed to 510(k) submissions, PMAs, PMA supplements, and IDE submissions for sterile and non-sterile Class ll and Class lll devices. Stephen also served as point contact for FDA and NB design control audits of Design History Files.
Stephen has led international teams from the U.S. and Europe, working extensively with surgeon KOL’s to identify clinical needs and develop implant and instrument systems to meet those needs. He has authored or co-authored numerous peer reviewed articles, patents, and white papers. Stephen lived and worked in Switzerland for two years and is conversant in English, French, and German.
Sharyn Orton, Ph.D., 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.
Jose Reyes-Marquez, Quality Consultant
Jose has over 28 years of experience in medical device and pharma quality systems, quality engineering, supplier quality, engineering, and regulatory compliance in the U.S. and Puerto Rico. He is an ASQ Certified Manager of Quality/Organizational Excellence, a Certified Quality Engineer, a Certified Quality Auditor, and Six Sigma Green Belt.
Throughout his career, Jose has held various industry management positions. He was Manufacturing Engineering Manager for five business units at Stryker, a leading medical device company in orthopaedics, medical and surgical products. At Corning Inc., a world leading innovator in materials science, ceramics, and products to accelerate drug discovery and delivery, Jose was a Quality Manager responsible for implementing Quality Management Architecture.
Jose has also led and provided training in key QMS and quality engineering roles entailing design control, risk management, CAPA, complaint handling, supplier management, investigations, quality audits, change control management, new product development, validations, and ISO assessments for Fortune 500 companies like Becton Dickinson, J&J, Eli Lilly, GSK, and Alcon (Novartis).
He is a Senior Member of ASQ, is an active committee leader and presenter for the Corning-Elmira ASQ section, and a member of the Rochester Professional Consultants Network in New York. Jose also volunteers for the Hispanic Inspiring Student’s Performance and Achievement (HISPA) organization as a role model, inspiring young students to pursue career and higher education goals. He holds a Bachelor’s degree in Industrial Engineering from the University of Puerto Rico (Mayaguez Campus) and is fully bilingual in English and Spanish.