Device Changes and the 510(k) 2016

Topics

• FDA`s and EU`s emphasis
• U.S. FDA device clearance / approval
• Tracking and evaluating changes – the "tipping point"
• Product changes and filing a new 510(k) clearance – who`s responsible
• K-97-1 and the FDA`s medical device approval
• Is the process "risk based"?
• Resolving wrong 510(k) submissions
• Documenting the process / rationale

Who should Attend

• Senior Management, Project Leaders, Internal / External Consultants
• Who Will Benefit
• Quality Systems Personnel
• Regulatory Affairs Personnel
• Personnel involved in Lean and Six Sigma Initiatives
• R&D and Engineering Staff
• CAPA Personne