About this Event
What Every Medical Device & IVD Founder Needs to Know
Featuring Heinz Steneberg, Regulatory Affairs & Quality Management Advisor at Daybreak Labs
Building a medical device or in vitro diagnostic (IVD) startup? Regulatory strategy can feel overwhelming, especially when you’re navigating limited resources, complex requirements, and pressure to get your product to market.
Join Daybreak Labs for a Lunch & Learn withHeinz Steneberg, our new Regulatory Affairs & Quality Management Advisor, for a practical discussion on what founders need to know to navigate the regulatory landscape, make smarter early-stage decisions, and build a path toward market access.
What You’ll Learn
- Regulatory Strategy: Why You Need It Sooner Than You Think
- Where Should You Start on a Startup Budget?
- Product Classification: The Consequences of Intended Use
- Hot Topics: AI, Wearables & Wellness
- Thinking Beyond the US
- Leveraging US Authorizations
- EU MDR & IVDR
Meet the Speaker:
brings more than 25 years of experience in regulatory affairs, quality systems, and clinical roles across the US medical device and diagnostic industries.
In his current role as a Regulatory and Quality Systems Consultant, Heinz supports IVD and medical device startups in developing and executing regulatory strategies, including initial engagement with the FDA.
Throughout his career, Heinz has held leadership positions at Quest Diagnostics, Carl Zeiss Meditec, Roche Molecular Diagnostics, Abbott Diabetes Care, and Medtronic’s Spine & Biologics and Vascular divisions. His experience includes regulatory and clinical submissions across IDEs, INDs, BLAs, PMAs, 510(k)s, and EU MDR and IVDR dossiers.
His expertise spans a broad range of technologies, including AI-enabled products, Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), electromedical devices, coronary and spinal implants, active implants, and IVDs covering infectious diseases, companion diagnostics, patient self-collection, and blood screening.
Earlier in his career, Heinz worked in TUV Rheinland North America’s Medical Division, where he progressed from quality systems auditor to division manager, supporting US companies with CE marking. He began his career as a Development Engineer at Biotronik in Berlin, Germany.
Bring your questions and get practical insights from an experienced regulatory professional who understands the challenges of bringing innovative medical technologies to market.
Agenda
🕑: 12:00 PM - 12:20 PM
Lunch & Networking
🕑: 12:25 PM - 01:10 PM
What Every Medical Device & IVD Founder Needs to Know
🕑: 01:10 PM - 01:30 PM
Q & A
Event venue & nearby stays
7683 Southfront Rd suite 230, 7683 Southfront Road, Livermore, United States
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