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Regulatory strategy is foundational for medtech startups and must be integrated early in product development. This workshop provides an essential introduction to the medical device regulatory landscape, beginning with device identification and the FDA’s classification system.

Participants will learn how a product’s intended use drives development and regulatory requirements, followed by a practical walkthrough of the 510(k) submission process. Topics include identifying predicate devices, demonstrating substantial equivalence, and understanding review timelines and associated costs.

The session also addresses more complex regulatory pathways such as De Novo and combination products, along with an overview of aligning early development with international standards and Quality Management System Regulation (QMSR) requirements.
 

Designed for founders and teams building medical devices, this workshop provides clarity, reduces risk, and supports smarter regulatory planning from day one.

Who Should Attend

• Medtech startup founders and co-founders

• Product development and engineering teams

• Regulatory, quality, and operations leaders

• Early-stage medical device companies planning FDA submissions

• Teams seeking clarity on regulatory pathways before scaling development