Training

Public Training: Technical documentation and Clinical Evidence for existing devices (London)

April 06, 2020

Date: 6th and 7th of March 2020

Location: London

Language: English

Costs: Regular € 1750.- (including lunch & drinks)

Introduction:

There is an enormous amount of work required to transition from the IVDD to the IVDR, manufacturers need to recognize that the IVDR is more complex and detailed and will, therefore, require more recourses to maintain as well as implement. 

Learning objectives: 

  • Preparing technical files

  • What are the requirements

  • What data do you need and what sources can you use

  • Creating files that are easy to review

  • Understanding Clinical Evidence requirements for existing devices

  • Scientific validity, Analytical Performance, Clinical Performance

  • PEP and PERs

More detailed information about the training will follow soon.
Sue Spencer
Post date: December 11, 2019
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