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Device Changes and the 510(k) 2016
15 Mar 2016
Webinar
Home
Device Changes and the 510(k) 2016
Key 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
Read more
Past Events
Device Changes and the 510(k) 2016 - 15 Mar 2016, Webinar
(57874)
Device Changes and the 510(k) 2026
Important
Please, check "Device Changes and the 510(k)" official website for possible changes, before making any traveling arrangements
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Health & Medicine:
Medical device, Medical technology
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