Balancing Innovation and Compliance in Medical Device Development

Product development lives at the intersection of creativity and compliance. You need to move fast, prototype freely, and respond to evolving requirements while satisfying regulatory expectations like FDA 21 CFR Part 820 and ISO 13485 design controls.

This webinar explores how to embed innovation into your design and development process without losing sight of traceability, documentation, or quality. Whether you’re a startup or a scaling team, we’ll walk through actionable strategies to balance speed with structure so your DHF becomes a competitive advantage, not a bottleneck.

What you’ll learn

Embed innovation without compromising compliance

How to apply human factors and user-centered design from the start
Using iterative prototyping and testing within regulatory frameworks

Streamline design control documentation

Translate creative ideas into compliant design inputs and outputs
Maintain traceability across inputs, outputs, verification, and validation
Avoid common pitfalls like versioning issues, risk gaps, and change control delays

Turn design reviews into collaboration tools

Make cross-functional reviews checkpoints for innovation, not just gates
Build a shared regulatory mindset across product, clinical, and quality teams

Accelerate your path from concept to commercialization

Use verification and validation as innovation validation, not just compliance
Simplify design transfer while preserving design intent

Watch on demand

Who should attend?

Medical Device Executives
Product Development Engineers and Management
Quality Professionals and Management
Regulatory Affairs Professionals and Management
Clinical Affairs Professionals and Management

QMSR is coming. Is your quality system ready?