510(k) Preparation with New Released FDA Guidance on Product Modifications 2016
17 Nov 2016
Webinar
Description
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)
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
