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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
In the popular television series “Survivor,” contestants are left on an isolated island with the odds stacked against them; they fight for survival amid constantly changing rules. Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to be an early exit from the FDA island with little chance of being “the survivor.” Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to survive on the show. Unlike TV—there is plenty of room for more than one to survivor!
Most medical devices come to the American market through the 510(k) program. Although the regulations haven’t changed, the FDA has reshaped and expanded its expectations, leading to ever-increasing complexity in submitting 510(k) applications. In this two-day, in-person workshop, regulatory experts will review the program’s requirements and expectations, provide strategies to help ensure success with program submissions, and arm you with the tools to be a “survivor.”
January 6, 2023 — March 20, 2023: Early Bird $1,135.00 Member | $1,340.00 Nonmember
March 21, 2023 — April 20, 2023: Regular $1,340.00 Member | $1,570.00 Nonmember
Upon completion of this workshop, participants should be able to:
Regulatory Affairs Professionals.
April 20, 2023
April 21, 2023
Instructors:
Mark DuVal, J.D.
Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional-supplement industries. His practice provides strategic regulatory advice, develops compliance programs, designs and implements sophisticated marketing programs, counsels on reimbursement matters, conducts sales training, teaches interfacing with the FDA in relation to product approval and clearance, and advises on clinical trial negotiations, approvals, policy arguments, and appeals. He works extensively with the FDA on 510(k)s, de novos , PMAs and combination products, IDE negotiations, pre-submissions, inspections, warning letters, appeals, and more.
Lisa Pritchard
Lisa Pritchard, BSEEE, is VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional-supplement industries. With more than 30 years of experience, she advises clients on regulatory, quality and compliance topics. Pritchard works extensively on worldwide regulatory strategies, marketing submissions and applications spanning the US, the EU and extending to Australia; quality system strategies, SOP development and review, and compliance. Prior to joining DuVal & Associates, she worked at a variety of device companies including American Medical Systems, Medtronic, Uromedica, and EnteroMedics. She brings extensive experience in strategy development, submission preparation, regulatory body negotiations, advertising/promotional materials assessment, inspection/audit preparation and conduct, quality system design, risk assessment, development of design control documentation, usability evaluations, clinical trial design, and adverse event reporting. Pritchard holds a B.S. in electrical and electronics engineering from North Dakota State University.
Anike Freeman
Anike Freeman received her B.S. in Bioengineering from the University of Maryland, College Park. Upon graduation, she began working at FDA as a research fellow in the Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH) and then transitioned to working as a biomedical engineer and reviewer in what is now the Office of Product Evaluation and Quality. She primarily reviewed 510(k)s and pre-submissions for various dental devices such as orthodontic appliances, restorative materials, dental implants, and bone grafting materials. While working, Anike earned her M.Eng. in Bioengineering from the University of Maryland, College Park and transferred to CDRH's Division of Industry and Consumer Education (DICE) as a Consumer Safety Officer. She educated industry on how to comply with U.S. medical device regulations and served as the DICE subject matter expert for medical device adverse event reporting, 510(k)s, and dental devices. She was later promoted to Senior Consumer Safety Officer where she managed division operations for several years. During this time, she received the CDRH Lireka P. Joseph Award for Excellence in Public Health Communication and Education. She now leverages over 10 years of FDA experience in her current work as a consultant at RQM+.
Ken Skodacek
Dongbo Wang
Dongbo Wang, Ph.D. is Senior Director of Regulatory at Galvanize Therapeutics. Galvanize Therapeutics is a Bay Area start-up company creating non-thermal pulsed electric field based devices for pulmonary and cardiac indications, regulated through both 510(k) and PMA pathways. Prior to joining Galvanize he worked in FDA/CDER/OPEQ regulating dental, general surgical and respiratory devices. Throughout his FDA career he primarily reviewed CDRH premarket submissions – 510(k)s, IDEs, de novos, PMAs, and combination products (device led, drug led, and biologics led). He is very much enjoying the transition to industry and collaborating to create innovative medical devices.
RAPS has initiated a Be Well policy, with consent required during the registration process. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while onsite at RAPS HQ, you will reconsider your participation at the event. To ensure your personal safety and comfort during this event, RAPS is committed to robust and transparent communications during the event. We encourage all participants to monitor RAPS social media channels and download the conference app to their mobile devices to receive up-to-the-minute updates.
All cancellation requests must be submitted in writing to support@raps.org. Cancellation requests received by March 17, 2023, will receive a full refund minus a 20% administrative fee. Cancellation requests received after March 17, 2023, will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.