Regulatory Strategy Lab: 510(k), De Novo, or PMA?

Leave with a structured decision framework for your next FDA submission.

#MEDeviceBoston

Find the Right FDA Pathway With Confidence

Choosing the wrong regulatory pathway can cost your team months and significant resources. This interactive lab puts you inside a real device evaluation scenario, guiding you through classification research, predicate strategy, risk profiling, and timeline planning. Leave with a structured decision framework you can apply to your next submission immediately.

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Why Attend this Workshop

Classification Confidence

Learn how to determine the correct classification for your device using FDA databases and guidance.

Pathway Clarity

Explore the specific factors that differentiate 510(k), De Novo, and PMA and how to evaluate which fits your device.

Strategic Planning

Discover what each pathway means for your development timeline, budget, and overall submission strategy.

FDA Engagement Strategy

Know when and how to engage FDA via Q-Sub to reduce submission risk and get early alignment on your pathway.

Workshop Breakdown

Four hands-on exercises. Real tools. A decision framework you can use immediately.

Device Case Study

Work through a realistic device case study built to mirror actual submission scenario complexity.

Classification Research

Use FDA excerpts to research device classification and build the foundation for your pathway recommendation.

Regulatory Decision Matrix

Build a structured decision matrix that maps classification, predicate strategy, risk profile, and timeline implications.

Pathway Presentation and Feedback

Present your pathway recommendation to the room and receive direct feedback from the workshop facilitator.

Who Should Attend

Regulatory Professionals

Regulatory Affairs Specialists
Regulatory Affairs Managers
Regulatory Compliance Engineers
Validation Engineers
Post-Market Surveillance Specialists

Engineering and R&D Professionals

Biomedical Engineers
Product Development Engineers
Design Engineers
Systems Engineers
R&D Leaders and Program Managers

Business & Growth Leaders

Startup Founders and Executives
Product and Program Managers
Business Development Professionals
Clinical Affairs Managers
Investors and Innovation Partners

Get More With the Full Conference Pass

Get full access to all conference education, workshops, and expo sessions at MEDevice Boston when you register for the MEDevice Conference. Claim your pass and learn the complete framework for building, scaling, and growing a successful medical device company.

What’s Included With Your Conference Pass

Every Hands-On Workshop

Right-Sized Quality Systems, Regulatory Strategy Lab, Design Controls in Practice. Solve the full spectrum of compliance and development challenges.

Three Conference Tracks

Every session covering regulatory updates, MedTech technology, and growth & investment strategies over two full days of expert-led content.

The Full MEDevice Experience

200+ exhibitors, show floor education, the Innovation Lab, networking events, and complimentary refreshments across both days.

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