Lunch and Learn: Regulatory Considerations for Start-up Companies

Join us for an essential lunch and learn session designed specifically for start-up companies navigating the complex world of medical device and diagnostic regulations. This interactive session will equip entrepreneurs and early-stage companies with the critical knowledge needed to build regulatory compliance into their product development strategy from day one.

What You'll Learn:

• The importance of early regulatory engagement - Understand why early engagement in regulatory affairs is critical for the development of a medical device or diagnostic
• Key components of a robust regulatory strategy - Identify the essential elements of a successful regulatory strategy
• Quality management system aspects - Learn why implementing a quality management system should precede the product development process

This session is perfect for founders, product managers, and team members at start-up companies developing medical devices or diagnostics who want to avoid costly regulatory pitfalls and accelerate their path to market.

About the Speaker: Heinz Steneberg currently serves as President & CEO of MDSS USA. With over 25 years of experience in the medical device and diagnostic industries, Heinz brings unparalleled expertise in Regulatory Affairs, Quality Assurance, and Clinical Affairs. He has successfully led regulatory submission projects including IDEs, PMAs, 510(k)s, and EU MDR & IVDR dossiers. His leadership experience includes 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.

Light lunch will be provided. Come ready to learn, network, and ask questions!

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