MS-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.
Steve C de Baca
Sr. VP of Global Quality & Regulatory -
- Responsible for the Quality Assurance system and over 400 person organization at the Maple Grove/Plymouth, MN, and two CA facilities and for the Design Assurance functions for new product development for the Cardiovascular division.
Clinical Research Director
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.
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, CMDR
- 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.
Director of 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, MBA, RAC
Fellow, Global Regulatory Affairs —Boston Scientific
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.
Doyle "Chip" Whitacre
Retired Sr. Director, Global Regulatory Operations — Medtronic, Inc.
- Over twenty-five years in the medical device industry working in research, operations, quality, clinical and regulatory affairs supporting a variety of products and services. Experience working strategic regulatory affairs in international markets, particularly in Asia-Pacific.