Talk
Streamlining success: navigating preclinical to pre-market pathways for study approval
Tue, Jan 28, 2025 · 9:30–10:00 AM CET Holiday Inn Munich City Centre
About this session
Navigating the journey from preclinical studies to market approval is a critical and complex process for medical devices. This presentation outlines a streamlined approach to ensure regulatory compliance, efficient development, and timely market access
- The importance of correct device classification and its impact on regulatory pathways.
- Strategies to define a comprehensive regulatory roadmap tailored to global requirements.
- Key preclinical tests to establish safety and performance baselines
- Insights into aligning preclinical findings with a robust clinical protocol
- Criteria for selecting the right Notified Body to streamline certification
- Best practices for creating a well-structured technical file to facilitate regulatory review
