Explore regulatory strategies for medical device start-ups, including FDA pathways, early planning, and building effective quality systems.
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.
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
Hologics GCD 1-Auditorium
10210 Genetic Center Drive
San Diego, CA 92121
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President & CEO, MDSS USA
Heinz Steneberg is a seasoned professional with over 25 years of experience in the medical device and diagnostic industries. Throughout his extensive career, he has held roles in Regulatory Affairs, Quality Assurance, and Clinical Affairs. He has led many successful regulatory submission projects, including IDEs, PMAs, 510(k)s, and EU MDR & IVDR dossiers, as well as submissions to regulatory agencies in Asia and South America. He served as the management representative and as the Person Responsible for Regulatory Compliance (PRRC).
With a unique perspective gained from leadership roles, including VP of Regulatory Affairs at MTL, Executive Director of Regulatory and Quality Management at Quest Diagnostics, Head of Regulatory and Clinical at Carl Zeiss Meditec, and Director of Regulatory Affairs at Roche Molecular Diagnostics, as well as his foundational experience as a Division Manager at TUV Rheinland of North America's Medical Division, he is well positioned to offer clients the strategic advice needed to navigate product approvals and market access.
His passion is to work with innovative companies to accelerate the development of new medical and diagnostic solutions for patients.

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.

Managing Partner, EvoNexus
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.
Founder & Owner, MDSS GmbH
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.

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.

COO, PRN Medical
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.We have completed our migration to a new platform and are pleased to introduce the updated site.
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