Device Changes and the 510(k) 2016 is a webinar that covers topics such as:
- 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
Device Changes and the 510(k) 2016 is intended for:
- 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