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.
Attend this 510(k) webinar to understand how to use the power of current risk management tools to do analysis, how to make the process risk based, how to document it, how to resolve a wrong decision.
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
- Production
- Engineering & R&D
