Medical Device Changes and the 510(k) 2014 is a webinar that covers topics such as:
- How to provide tools to document such decisions
- Deciding When to Submit a 510(k) for a Change to an Existing Device, K97-1
- How to structure a decision matrix to document change decisions
- It will discuss how companies can best document their decisions -- whether or not a new 510(k) filing is warranted
- Who makes the decisions and how to defend them
- How to evaluate changes that could trigger the "Tipping Point"
- Preparing for further 510(k) changes in the future
- How to implement formal methods with documented, and defensible rationale
Medical Device Changes and the 510(k) 2014 is intended for attendees from companies in the Medical Device and combination products fields involved in:
- Engineering Staff
- Research & Development
- Regulatory Affairs
- Quality Assurance
- New Product Development
- Lean & Six Sigma staff
- Mid-level and Senior Management
- Marketing
- Consultants
- Project Leaders
