510(k) Preparation with New Released FDA Guidance on Product Modifications 2016

  • 17 Nov 2016
  • Webinar

Description

510(k) Preparation with New Released FDA Guidance on Product Modifications 2016 is a webinar that covers topics such as:

  • 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

510(k) Preparation with New Released FDA Guidance on Product Modifications 2016 is intended for attendees from:

  • QA
  • Engineering personnel
  • Management
  • Software developers

Past Events

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

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