FREE ON-DEMAND WEBINAR
November 7, 2024

The Importance of Integrating Regulatory Early into Product Development

Building a multidisciplinary team during the Concept phase is essential for avoiding costly rework, FDA delays, and misallocated resources.

Even seasoned companies often involve regulatory too late—when designs are locked, and changes are costly. Conducting a preliminary regulatory assessment in early development informs critical aspects like intended use, testing requirements, and the regulatory pathway, shaping the entire project roadmap.

If you want to get somewhere, why would you start building the road before you know the destination?

Join us for an insightful webinar with Kara Johnson, VP of Regulatory Affairs at Kapstone Medical, as she breaks down actionable steps for integrating regulatory strategy from day one to minimize risk, ensure compliance, and maximize your chances for market success.

Specifically, this webinar will help you:

• Know when to involve regulatory: Understand the right stage in product maturity to initiate regulatory assessments.
• Conduct a preliminary regulatory assessment: Identify classifications, map submission needs, and applicable standards.
• Scope your regulatory strategy: Plan for design considerations, testing, and documentation.
• Adapt as design evolves: Learn why regulatory strategies should be revisited as your product advances.
• Avoid common pitfalls: See real examples of costly mistakes that could have been prevented through early regulatory planning.