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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
Workshop sessions 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 will provide critical knowledge for anyone new to the medical device industry, planning a career in medical devices or looking for a way to refresh and enchance their regulatory knowledge.
Member $75 | Nonmember $175 | Student $50
RAPS members, please use this code to receive the discounted price for RAPS members: 2023RAPS
Participants in this full-day workshop will develop an understanding of the steps in he process iof bringing a medical deviice to market, including clinical trials, 510(k) and De NoVo submissions, quality systems, working with the FDA and advertising and promotional practices.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Anyone new to the medical device industry or interested in a career in medical devices, people whose job responsibilities intersect with medical device development or regulation, and people in the industry interested in hearing from some of the most respected experts in the field.
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.
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.
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.
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.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email email@example.com.