510(k) Preparation with New Released FDA Guidance on Product Modifications 2016
17 Nov 2016
Webinar
Key Topics
What is Refuse To Accept policy?
Unique terminologies in 510(k)
Selecting a predicate device (substantial equivalence)
What is a predicate device?
How to handle software?
Where to find substantially equivalent predicate devices?
510(k) procedure for device modifications
Who should Attend
Attendees from:
QA
Engineering personnel
Management
Software developers
Past Events
510(k) Preparation with New Released FDA Guidance on Product Modifications 2016 - 17 Nov 2016, Webinar (63510)
510(k) Preparation with New Released FDA Guidance on Product Modifications 2026
Important
Please, check "510(k) Preparation with New Released FDA Guidance on Product Modifications" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Healthcare, Medical device, Pharma
