Training

MDR Suite | Technical Documentation

September 30, 2021

Date: 30th of September 2021

Time: 15:00h -17:00h CET 

Location: Virtual

Language: English

Costs: € 395,-

Package deal (12 sessions): € 3750.-  *

* Team Members with Different Roles & Responsibilities? No problem!
We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package
.

Introduction:

The EU-MDR introduces a new view on technical documentation, that is broader than the current view on technical files and design dossiers (class III). It differentiates between data needed prior to market access (MDR annex II) and post-market data (annex III). With all the changes one can only conclude that all technical files and design dossiers need to be to match the EU-MDR requirements.

Learning Objectives:

  • Understand the set up and contents of Technical Documentation according Annex II
  • Understand the set up and contents of Technical Documentation on Post-market Surveillance according Annex III
  • Learn the level of depth of supporting evidence needed
  • Understand that ‘the devil is in the details’

Trainer: 

Stefan Menzl
Post date: March 22, 2021
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