This 510(k) webinar training will discuss how to do a meaningful result drive 510(k)/change analysis activity so as to satisfy FDA requirements.
Areas Covered in the Seminar:
- Key requirements of the three types of 510(k)s.
- Product changes and filing a new 510(k) – who's responsible.
- U.S. FDA device clearance / approval.
- Using FDA's K97-1 Memo.
- Tracking and evaluating changes – the “tipping point”.
- Making the process "risk based".
- Documenting the process and rationale.
- Resolving a "wrong" decision .
Who Will Benefit:
All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)'s, and then document their decisions in harmony with regulations:
- Senior management
- Regulatory affairs
- Quality Assurance
- Engineering & R&D
For More Information: