Southern California LNG In Person Event: Regulatory Considerations for Medical Device Start-up Companies

Heinz Steneberg

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.

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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.

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Ludger Moeller

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.

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Coco Oxford

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.

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Carrie Beth Johnson

Business Development Manager , Intertek

Carrie Beth Johnson is a Business Development Manager at Intertek, supporting regulatory and quality professionals across the medical device and regulated health and wellness sectors. She partners with organizations to navigate global compliance and certification frameworks, including ISO 13485, MDSAP, and cGMP.

Carrie Beth brings a practical, business-aligned approach to regulatory strategy, helping teams translate evolving requirements into clear, actionable compliance programs that support market access and effective risk management. She is known for her engaging and approachable style, and regularly contributes to industry panels, webinars, and Regulatory Affairs Professionals Society (RAPS) chapter discussions.

She holds a bachelor’s degree from Pepperdine University and is a Registered Yoga Teacher, bringing a thoughtful, relationship-driven perspective to complex regulatory conversations.

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Harry Blumsack

CEO, Infera

Harry is the CEO of Infera, the first AI-native quality and regulatory compliance platform for medtech. With a background in engineering, device development, and regulatory strategy, he has spent his career helping teams build and scale complex systems in regulated environments. He founded Infera to help medtech companies build safer products, faster — driving innovation while meeting the highest standards of safety and efficacy.

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Carl Manthe MBA, PMP

Consulting Director , Integrated Project Management Co., Inc. (IPM)

Carl Manthe, MBA, PMP, Six Sigma Black Belt, is a Consulting Director at Integrated Project Management Co., Inc. (IPM), where he leads the Los Angeles office. He brings extensive experience across pharmaceutical, biotech, and medical device industries, specializing in program and project management, regulatory and quality, commercialization, and business transformation initiatives.

With a Kellogg MBA and a background in leading complex global programs, Carl has helped organizations drive strategic execution, optimize processes, and successfully deliver high-impact projects across the life sciences and healthcare sectors.

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Neil Kelly MBA, RAC

Senior Director of Global Regulatory Affairs , Hologic, Inc.

Neil Kelly is a Senior Director of Global Regulatory Affairs with more than 20 years of experience across medical devices, biologics, and in vitro diagnostics. He has built deep expertise in Class I, II, and III medical devices, including capital equipment, single-use disposables, mammography, and software as a medical device, with regulatory leadership spanning the U.S., Europe, Canada, Latin America, and Asia-Pacific.

In his current role, he leads corporate-wide regulatory strategy initiatives, supporting standards management, regulatory intelligence, regulatory information management systems, labeling, and broader global regulatory affairs implementation activities. He is known for combining strategic regulatory insight with strong cross-functional leadership, helping organizations improve processes, reduce risk, and maintain robust, compliant documentation while advancing business goals.

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