A brilliant design for a medical device means nothing if you can’t get it past the scrutiny of a regulatory body (e.g, FDA). This full day workshop will provide insights into the basics of medical device regulations to help you understand activities needed to bring a medical device to market and to successfully navigate the ever-increasing challenges of this exciting field.
This workshop will include an introduction to US regulations and working with the FDA, conducting clinical studies, design of quality systems, submission pathways, as well as advertising and promotion requirements, and working with FDA. All sessions will be conducted by some of the most respected experts in the field. This workshop imparts critical knowledge for anyone who is new to the medical device industry or hoping to join it. And if you’ve been in the industry, it’s always a great idea to refresh your knowledge.
Welcome address from Art Erdman, DMD Conference Chair and Christina Pecoraro, RAPS Twin Cities Chanpter will kick off the day at 8:00am CDT.
8:05 am - Introduction to Medical Device Regulations
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.
9:00 am - 510(k) and De Novo Submissions
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, Sr. Regulatory, Quality, and Compliance Consultant, 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.
10:00 am - Pre-market Approvals (PMAs)
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).
10:45 am - Advertising and Promotional Practices
Sr. Director Legal-Regulatory and Compliance, DuVal & Associates, P.A.
Aaron Hage, JD, RAC, is a Sr. Director Legal-Regulatory and Compliance at DuVal & Associates, P.A., a law firm 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.
11:15 am - Clinical Trials & Investigational Device Exemptions (IDEs)
President and CEO, Frestedt, Inc.
Dr. Frestedt has over 40 years of experience in clinical research, regulatory negotiation, quality system development and business leadership in the pharmaceutical, medical device, and food industries. She has experience running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and quality system management to compete globally. Dr. Frestedt has served as Regulatory Director at the University of Minnesota Academic Health Center, as a member of the Allina IRB and she previously held key positions at Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca, and Orphan Medical. She holds a B.A. from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School. Dr. Frestedt is a member of American Society of Clinical Oncology (ASCO), Society of Clinical Research Associates (SoCRA), and is a Fellow of Regulatory Affairs Professionals Society (RAPS) and Association of Clinical Research Professionals (ACRP). Author of FDA Warning Letters about Food Products: How to Avoid or Respond to Citations (Elsevier, 2017) and Warning Letters: 2016 Reference Guide (Barnett International, 2016), Dr. Frestedt was honored in 2011 as one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE and one of the top 25 “Industry Leaders,” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal.
1:15 pm - Quality Systems Overview
Partner Steve has been a leader in Quality Systems management for 30 years. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican Biothermal, St. Jude Medical, Boston Scientific, Medtronic, and Vital Images,. Steve also helped develop and is an Adjunct Instructor in St. Cloud State University’s M.S. in Medical Technology Quality program. He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, auditing, project management, and configuration management.
2:00 pm - Introduction to EU/International Regulation
Sr Regulatory and Clinical Evidence Specialist, Evenson Regulatory Consulting
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.
3:00 pm - Risk Management
VP Global Regulatory Affairs
Oriel STAT A MATRIX – A Validant Company
Richard brings more than 30 years of global medical device, IVD, and pharmaceutical quality and regulatory experience to each customer engagement, employing his extensive expertise in regulatory strategy, regulatory classifications and submissions, risk management, software-driven products, post market surveillance, complaint handling, adverse event reporting, inspection readiness, and auditing. As the key leader in global regulatory affairs for Oriel STAT A MATRIX, Richard has supported medical device organizations of all sizes to understand the changes in the worldwide device regulations and how they will affect their compliance gaps, and to plan for and implement their transition to changes in regulations.
3:45 pm - Working With FDA: Inspections, Enforcement, and other topics
Deputy Program Director, Office of Medical Devices and Radiological Health Operations (OMDRHO), ORA, US. Food & Drug Administration
Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years. She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA. She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects. Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office.