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How to Find and Effectively Use Predicate Devices

$49.00

In this Meditrial Video Course you will learn about critical decision points in the decision-making process FDA uses to determine substantial equivalence.

Description

Welcome to the HOW TO FIND AND EFFECTIVELY USE PREDICATE DEVICES training.
In this training you will learn about critical decision points in the decision-making process FDA uses to determine substantial equivalence.
After the course, you can take a brief test to receive the certification. Enjoy!

 

TOPICS

  • Regulatory Information & Submission Preparation (00:05:09)
  • Predicate Devices (00:03:05)
  • How do I find a Predicate Device? (00:03:24)
  • Choosing a Predicate Device that fits best (00:15:21)
  • NSE – Not Substantially Equivalent (00.03.09)
  • Sample of 510(K) Summary (00:01:08)

  • Final Test
  • Course evaluation survey
  • Certification

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