Regulatory 101: Medical Devices

Jackie Torfin
CEO, Principal Advisor at QLear Advisors

Jackie Torfin has been a leader in MedTech and Biotech companies for 30+ years. She has had roles in quality, regulatory, project management, pre-clinical and clinical compliance. She has a BS in Medical Technology, a Master's in Leadership, and has been Adjunct Faculty for 10 years at St. Cloud University in the Master's in Medical Technology Quality and Regulatory Science Programs. She is CEO and Principal Advisor at QLeaR Advisors, a consulting firm focused on quality and regulatory compliance for MedTech and Biotech companies.  She focuses on Compliance Leadership mentoring/coaching, due diligence, and remediation activities. 

James Kleinedler
Director, Regulatory Strategy, Medtronic

Jim Kleinedler is the Director of Regulatory Strategy in Medtronic’s Global Regulatory team where he serves as a strategic resource for innovative programs across the product lifecycle. Dr. Kleinedler joined Medtronic from Boston Scientific, where he drafted IDEs, 510(k) and PMA submissions and worked with regulators to align on strategies with a focus on IRB/EC submissions, early feasibility studies, and breakthrough device designations for emerging interventional cardiology technology. He is a former FDA device reviewer, where he led premarket review of Class II & III cardiovascular device applications and served as a biocompatibility focal point within CDRH. Dr. Kleinedler earned his B.S. in Chemical Engineering from Iowa State University, and Ph.D. in Toxicology from LSU. He is the author on 10 peer-reviewed publications, inventor on seven medical device patents, and is an adjunct instructor in St. Cloud State University’s graduate program in regulatory affairs.

Mac McKeen, RAC, FRAPS
Fellow, Regulatory Science, Boston Scientific Corporation

Mac McKeen has over 30 years of experience in the medical device industry in regulatory and quality roles focused on the Total Product Life Cycle related to the product development, quality compliance, clinical study, and the regulatory submission and approval of cardiovascular devices and is currently a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize. Recently, Mac provides Regulatory guidance and leadership to Global Sterilization Operations and product supply chain programs and manages the FDA Master File Program for BSC. For the last 14 years Mac has served as an Adjunct Professor at the University of Minnesota instructing undergraduate and graduate level courses in the Technology Leadership Institute on medical device development. Mac holds a BS in Industrial Technology from Iowa State University and an MBA from the University of Dallas and is RAC certified and elected as a Fellow by the Regulatory Affairs Professional Society (F.R.A.P.S).

Lisa Pritchard
VP Regulatory, Quality, Clinical and Engineering

Lisa works extensively assisting clients with worldwide regulatory strategies, marketing submissions and applications (FDA submissions such as pre-submissions, IDEs, Breakthrough Device Designations, 510(k)s, De Novos, PMAs, Emergency Use Authorizations, and advisory panel meeting preparation; European Design Dossiers, Technical Files, and Clinical Evaluation Plans and Reports; Canadian license applications; and Australian listing applications); quality system strategies, SOP development and review, and compliance topics. Lisa brings over 30 years of experience in working with industry.

Kathy Herzog, BSME
Sr. Regulatory, Quality, and Compliance Consultant at DuVal & Associates, P.A.

Kathy Herzog, BSME, is a Sr. Regulatory, Quality, and Compliance Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She has worked in the medical device industry for over 30 years, primarily in the areas of product design and development, regulatory, and project/program management activities for class II and class III products in the cardiac, orthopedic, neuromodulation, and urological, therapeutic areas. She is experienced with US marketing submissions (Q-submissions, IDEs, 510(k)s, De Novos, Breakthrough Device Designation requests, Emergency Use Authorizations, HUDs/HDES, PMAs and PMA supplements) and regulatory strategy planning for US, EU, CAN, and AU submissions, labeling development, promotional copy review, Medical Affairs and off-label information management, risk assessment, adverse event reporting, quality system compliance, SOP development, and compliance training.

Aaron Hage, JD, RAC
Sr. Director Legal-Regulatory and Compliance, DuVal & Associates, P.A.

Aaron is dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Aaron has a wide-range of regulatory experience including Medical Device Reporting, Corrective Action/Preventive Action (CAPA), 510(k) submissions, PMA supplements, technical file reviews, advertising/promotional reviews, notified body audits, and FDA inspections. Aaron earned his Juris Doctor from William Mitchell College of Law, and his Bachelor of Science in Microbiology from the University of Minnesota – Twin Cities. Aaron holds a Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professional Society (RAPS) and is currently completing a Master of Science Degree in Regulatory Affairs and Services from St. Cloud State University. Aaron is also registered to practice before the United States Patent and Trademark Office.

Jennifer Mischke
Senior Vice President, Global CRO Services

Jennifer Mischke brings more than 20 years of clinical research and regulatory experience to her role as Senior Vice President of Global CRO Services at NAMSA. As a biostatistician working across device, diagnostic, and drug development, she has supported a range of research across therapeutic areas and regions of the world. Jennifer frequently interacts with FDA, has authored numerous regulatory submissions, manuscripts, and presentations, with a focus on statistics and scientific considerations. Jennifer also serves on advisory groups within the medtech industry, and is adjunct faculty instructing graduate-level biostatistics courses. 

Gourmet Box Lunches will be provided. Gluten Free and Vegan options will be available. If you have special dietary requirements, please email [email protected]. 

Kristen Evenson
Director of Regulatory Affairs, GT Metabolic

Kristen has worked with numerous companies ranging from start-ups to Fortune 500s, helping companies develop global regulatory strategies, write submissions, and negotiate with regulators and auditors. She has experience with FDA submissions (Q-Subs, 510(k)s, Breakthrough Device Designations, Emergency Use Authorizations (EUAs), Safer Technologies Program (STeP), Audits, etc.), EU CE mark submissions (Technical Files, Clinical Evaluation Plans/Reports (CER), Post Market Surveillance (PMS) Plans/Report, Post Market Clinical Follow-Up (PMCF) Plans/Reports, Period Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP) reports, technical file audits etc), UK CA mark submissions, Health Canada license applications, Australian applications, and more.

Mark Swanson
QRx Partners

Partner Mark has been a leader in Quality and Regulatory for over 25 years. His career includes roles in quality engineering, design assurance, audit, and quality management for companies including St. Jude Medical and Medtronic, and has provided guidance to numerous medical device and pharmaceutical manufacturers of all sizes. Mark is also an Adjunct Instructor in St. Cloud State University’s M.S. in Medical Technology Quality program. He holds a B.S. in Electrical Engineering from the Univ. of MN, an MBA from Argosy University, and certifications in quality management, auditing, and quality engineering. Mark was also a member of the working groups that developed the most recent updates to ISO 13485, ISO 9001, and ISO 14971, and serves on several AAMI committees.

Amra Racic
Veeva MedTech,

Susan Matthias
US Food & Drug Administration

Rhonda Mecl
Deputy Program Director, Office of Medical Devices and Radiological Health Operations (OMDRHO), ORA, US. Food & Drug Administration

Rhonda Mecl became the Deputy Program Director of Medical Devices and Radiological Health Operations (OMDRHO) in January 2023, after serving as the program's Operations Staff Director for the previous five years.   She has a wealth of FDA knowledge and experience having served more than 24 years in Office of Regulatory Affairs (ORA) managing staff primarily focused on medical devices, radiological health, and mammography quality inspectional operations.  She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners within the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects focused on continuous improvement.  Rhonda has more than 34 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office.