Launching a medical device start-up requires more than a great idea—it requires a thoughtful regulatory strategy from the beginning. Sponsored by MDSS and in partnership with Hologics and PRN Medical, this event will explore key regulatory considerations for early-stage medical device companies, including selecting the appropriate FDA pathway and preparing for regulatory submissions and global market entry.
Industry experts will share practical insights and lessons learned to help founders, innovators, and start-ups navigate regulatory challenges while supporting product development and commercialization. Attendees will gain valuable perspectives on regulatory strategy, global market access, and compliance considerations essential for successful product development.
Registration Fees & Deadlines
Member: $0 | Nonmember: $20 | Student: $0| Nonmember Student: $10 (With Promo Code)
*Please reach out to a RAPS Southern California LNG Leader to request a Student Promo Code.
Agenda
5:00-5:30 Registration & Networking
5:30-5:40 Welcome and Introduction
5:40-6:20 Panel 1: Regulatory Strategy
6:20-6:40 Networking Break
6:40-7:20 Panel 2: How to avoid common errors?
7:20-7:30 Wrap-up
Panelists:
Heinz has more than 20 years of experience in regulatory, quality management, and clinical roles in the medical device & diagnostic industry. He held leadership positions at Medtronic, St. Jude Medical, Abbott, Grifols, Roche Molecular Diagnostics, Carl Zeiss Meditec, and Quest Diagnostics.
His regulatory experience covers the entire medical device lifecycle from regulatory strategy development, submission, commercialization, and phase-out.
Quality management experience includes eight years as a lead auditor with an EU Notified Body and roles in building and sustaining quality management systems. He served as the Management Representative and Person Responsible for Regulatory Compliance.
Heinz started his professional career as an R&D engineer at Biotronik in Berlin, Germany, and currently serves as President & CEO of MDSS USA. He is based in the San Francisco Bay Area.
Charla Triplett
Head of Strategy, Partnerships & Growth, University Lab Partners
Charla Triplett is a seasoned innovation leader with more than 20 years of experience bridging academia, startups, venture capital, nonprofits, and industry. Trained as a bioengineer, she brings deep expertise across digital health, biosensors, medtech, and the life sciences. Charla was a Founding Partner at Suncoast Ventures and still serves as a deal flow advisor.
She currently serves as Head of Strategy, Partnerships & Growth at University Lab Partners (ULP), where she leads strategic initiatives, ecosystem development, and growth partnerships that accelerate early-stage science and healthcare ventures. Throughout her career, she has been a sought-after mentor, advisor, and ecosystem connector.
Her prior experience spans business development, strategic partnerships, biomedical engineering, interactive digital marketing, and medical device product development—consistently operating at the intersection of science, strategy, and commercialization.
Robert Genthert is Managing Partner at EvoNexus, a leading startup incubator supporting technology and life science innovation. He works closely with early-stage companies to help them develop scalable business strategies, connect with investors, and successfully bring new technologies to market.
Ludger Moeller is the owner of MDSS GmbH and the founder of several affiliated organizations including MDSS Consulting GmbH, ITN Holding GmbH, MDSS-UK RP Ltd, MDSS CH GmbH, MDSS USA LLC, MDSS Impex GmbH, and MDSS AU PTY LTD.
With a distinguished career spanning over two decades in the medical device regulatory sector, he has played a pivotal role in shaping compliance strategies and influencing regulatory frameworks across global markets.
Shep Bentley, RAC
Principal Consultant, Benley Biomedical Consulting LLC
“Shep” has 42 years of experience working in the medical industry, starting in 1984 as a research technician at Hospital Corporation of America. Subsequently, he has managed Kendall-McGaw Laboratories, Inc. parenteral and non-ethical drug production, TOSHIBA America Medical System’s crashcart/T1600 manufacturing, and in 1993 founded Rising Star, Inc. to produce a variety of assemblies for the biomedical industry. He sold this venture to Standard Industries in 1997, and by 2004, he set up a full service biomedical regulatory consultancy, Synergy Biomedical, LLC and concurrently Supercomal Medical Products (M) Sdn Bhd, a Malaysia-based CDMO. When Synergy Corp was acquired by ICF International in 2005, he spun off as Bentley Biomedical Consulting, LLC in 2006.
Since the establishment of his independent biomedical regulatory consultancy, Shep has worked closely with large companies (Fortune 500) and small ventures around the world to facilitate their interaction with the FDA, drafting submissions that apply various novel approaches to the portrayal of drug and device risks to patients, and clinicians. These submissions have produced competitive results for the companies, and he has served in the CEO role on multiple occasions. He speaks at symposia, conferences, and various biomedical/biotech events around the world (Europe and Asia) and has published articles and book chapters on regulatory affairs. He is retained by various laboratories (Eurofins, NAMSA, Intertek, etc.) for compliance.
Shep is an active member of the Orange County Regulatory Affairs (OCRA) Discussion Group, Regulatory Affairs Professional Society (RAPS), the Association for the Advancement of Medical Instrumentation (AAMI), the American Society for Quality (ASQ), and is a Member of The Organisation for Professional Regulatory Affairs (MTOPRA). He has actively maintained the Regulatory Affairs Certification (RAC) for U.S. medical regulation for the past 20 years.
Corina “Coco” Oxford serves as Chief Operating Officer of PRN, where she supports regulatory and operational strategy for medical device companies navigating global market requirements. She works with emerging and established companies to streamline regulatory processes and support successful product development and commercialization. Coco also serves as a Board Member of the Orange County Regulatory Affairs Discussion Group (OCRA-DG), supporting professional development within the regulatory affairs community.
Location
Hologics GCD 1-Auditorium
10210 Genetic Center Drive
San Diego, CA 92121
Sponsored
In Partnership with:
Gold Sponsors
Bronze Sponsors
MDSS USA (logo)
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
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.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.