Medical Device Changes and the 510(k) 2014

Key Topics

• 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

Who should Attend

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