RAS Instructors and Developers
Athula Abeyratne, Ph.D
Senior Principal Statistician-- Medtronic
- Athula has been working for Medtronic over 20 years as a statistician working with clinicians, scientists, engineers and others in variety of different applications of statistics including pivotal clinical studies and device manufacturing quality systems.
Prithul Bom, MBA, RAC, ASQ-CSQE
Senior Director, Scientific Strategy, Medical Device & Diagnostics Development
Started in the heathcare industry at an application developer in 1998. Nine years in medical device, 4 years combined performing third-party reviews of 510(k) under the FDA Accredited Person Program and regulatory/clinical/quality and scientific strategy. Well versed in regulatory considerations surrounding total product life cycle of a medical device or diagnostic. Guest lecturer, regulatory sciences, at The George Washington University, School of Medicine & Health Sciences, Washington D.C.
James M. Broge, Ph.D.
Director, Quality Systems
- Jim has led Quality teams in the Medical Food and Medical Device industries for over 20 years. Currently, he leads the Complaint Investigations, Trending & Analysis function as part of the Global Post Market Quality Assurance organization within Boston Scientific. His experiences include management of laboratories, quality systems, audits, and quality operations
Sr. Principal Regulatory Affairs Specialist - Medtronic
Barbara Chiponis, JD, MBA, RAC
Over 19 years in the medical device industry working with Regulatory agencies around the world to obtain product approvals of pacemakers, implantable defibrillators, RF ablation generators and catheters, in vitro diagnostics and drug delivery systems. Previously held leadership positions in Quality Systems hosting several successful FDA inspections and Notified Body audits.
President — DuVal and Associates, P.A.
- Over 15 years general counsel to 3M Pharmaceuticals, 3M Drug Delivery Systems, and later FDA and compliance counsel at Medtronic before starting his private practice specializing in FDA law and representing medical device, pharmaceutical and nutritional supplement companies.
President, Quality Management
Systems Potential, LLC
- Chad has five years in the medical industry and over 11 years of experience working in the medical device industry. Currently, he leads the Patient and Technical Services function as part of the Customer Support and Vigilance organization within Medtronic Neuromodulation business. His experiences within the medical device industry include management of global complaint handling and regulatory reporting, complaint investigations, compliance, patient services, and technical services.
Mary Beth Henderson, Ph.D.
— Regulatory & Clinical Research Institute (RCRI)
- 25 years or experience in the medical device and biotechnology industries in the area of regulatory affairs, quality systems, combination products, technology transfer, and intellectual property management.
Judith M. Hickey
President & Co-founder — Princeton Reimbursement Group
- More than 20 years experience in reimbursement and health care policy in the medical device and diagnostics industry.
Owner / Reviewer — Regulatory Technologies Services, LLC
- Eight years performing third-party reviews of 510(k) under the FDA Accredited Person Program, completing more than 300 510(k) submissions
President — Regulatory Strategies, Inc.
- Former Director of FDA's Office of Combination Products, with 17 years at FDA and 9 years in the medical device industry. Currently leads regulatory consulting practices specializing in medical device and combination products.
Marie DeGayner Kuker, Rph, FRAPS, RAC
President — Kuker Regulatory Consulting, LLC
- More than 25 years regulatory experience in the pharmaceutical industry before starting a regulatory consulting firm specializing in biomedical regulatory affairs.
President, KMLundberg Consulting, Regulatory, Clinical, Compliance for Med Tech Companies. Retired Sr. VP/Chief Compliance Officer - Boston Scientific Corporation
- A biostatistician with over 25 years experience in the medical device industry including Operations, Clinical Research, Human Resources, Regulatory Affairs, and Compliance and with more than 13 years experience as a Senior Executive with Guidant and Boston Scientific.
Christopher Lyle, M.S.
Principal Advisor and Director of Biostatistics & Information Systems — RCRI
- Directs data analysis and database development for RCRI, Inc. and consults on clinical trial design, analysis plan development and economic analyses.
QRCS Owner / Consultant / Notified Body Auditor NSAI
- 26 years in the medical device industry, 10 years Medical Technologist, 16 in regulatory and quality assessments and/or training with TUV SÜD, SGS, BSI, NSAI, primarily international, EU & Canada, auditing and systems development for QS and compliance to ISO 13485, FDA QSR, CMD
- Over 20 years of experience working in device regulatory affairs in small, medium, and large sized companies. Currently, a project manager and regulatory consultant on worldwide device regulatory registrations.
President — Technomics Research, LLC
- Over 20 years' experience working in and consulting to the medical device and pharmaceutical industries on statistics for clinical trial design and analysis, and on health economics for product value definition and coverage/reimbursement.
President, Japan Regulatory Solutions LLC
- Extensive experience working in both US and Japanese medical device industries, consults on regulatory submissions
and quality system applications for entering Japanese market.
Principal Regulatory Affairs Specialist, American Medical Systems
- Industry Representative to the FDA Neurological Devices Panel. Mr. Mueller has over 25 years of medical device industry experience including 3M, Medtronic, St. Jude Medical and private consulting in regulatory affairs, clinical, quality and toxicology/biocompatibility. Mr. Mueller has extensive experience in Class I, II and III neurological and cardiovascular devices as well as international biocompatibility, clinical standards and bovine spongiform encephalitis (BSE).
Sue Norenberg, BA, MBA
Senior Manager, Clinical Quality — Medtronic
- More than 25 years in the medical device industry, including R&D, clinical trial mgmt., pre-clinical, IDE and post market domestic and international studies, as well as regulatory compliance.
Vice President, Regulatory Affairs, Interventional Cardiology ----Boston Scientific
- Mr. Novak has over 18 years in the medical device industry working with Regulatory Agencies around the world to obtain approval of products such as pacemakers, implantable defibrillators and stents, and has previously held various positions in Engineering, Design Assurance, and Quality Systems.
Susan Petersen-Stejskal, RN, BSN
Vice President, Clinical Research — BioControl-Medical
- More than 25 years as research nurse clinician and manager and has three original panel track FDA PMA submissions with more than 20 PMA-S requiring prospective clinical data.
International Regulatory Manager — 3M
- With more than 12 years experience in the device industry he currently manages registrations and assures compliance with 3M subsidiaries around the world.
Dawn Stenstrom, MT(ASCP), MBA, RAC
Fellow, Global Regulatory Affairs —Boston Scientific
Over 15 years of regulatory experience in the medical device industry supporting cardiovascular, neuromodulation, spinal biologics, medical device software, and in vitro diagnostics products. Currently, providing strategic regulatory leadership on internal global regulatory policy and industry advocacy efforts.
Mark Swanson, MBA, ASQ CMQ/OE & CQE
Principal Consultant — H&M Consulting Group, LLC
- Experienced Project Leader and QA professional with strong medical device exp. incl. Risk Mgmt, V&V, and Reg. Submission
David A. Teicher, Esq.
Associate Attorney — DuVal and Associates, P.A.
- Nearly 30 years in regulatory affairs starting as a biomedical engineer investigator with the FDA for 11 years, then device companies, and for the last 3 years as an attorney at DuVal.
Director, Business Intelligence and Clinical Analytics —Park Nicollet Health Services
- Manages a performance analytics team at a large urban safety-net hospital. He has experience with healthcare economics, decision analysis, health insurance and finance with fortune 500 companies, nonprofits and startups.