Preclinical Considerations: Testing Regulated Wound Healing Devices

In today’s rapidly advancing medical device landscape, wound healing stands out as a top priority for innovation. Medical device manufacturers face many challenges in their product development and regulatory path for demonstrating the safety and effectiveness of new therapies in preclinical studies. In this webinar, NAMSA experts will offer valuable insights into regulatory considerations and testing strategies. Our speakers will provide a comprehensive overview of FDA and EU regulatory requirements, delve into testing strategies and share “tips and tricks” for navigating unconventional scenarios and novel devices.

Attendees can expect to walk away with a better understanding of:

• Regulatory Expertise: Gain in-depth knowledge of FDA and EU regulatory requirements to ensure your preclinical research and wound healing devices meet the current standards
• Testing Strategy Excellence: Discover essential testing strategies to optimize your preclinical studies for different wound healing therapies
• Navigating the Unconventional: Learn about options to consider for testing approaches when products are novel and DeNovo