How to write a technical file

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TRAINING

MDR/IVDR - How to write a technical file

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

 

 

 

 

 

 


 

Program overview

  • Annex II technical documentation – pre-market
  • Annex III technical documentation – post-market
  • Regulatory Lifecycle concepts, embedding PMS and PMCF
  • PSUR & SSCP requirements
  • Case studies
  • Questions & Answers
  • Evaluation of the Course and closing


Learning objectives

  • What do the authorities (Notified Body, FDA, CFDA) expect?
  • Manage the creation of technical files for the certification process for the European Union
  • Practical examples
  • Create technical documentation to support the product throughout its lifecycle. 
  • Learn to structure data and build technical documentation under MDR
  • Understand the full impact of the new EU-MDR on PMS and PMCF principles in continued market approval
  • Know how to apply PSUR and SSCP
  • Understand how to build and use checklists, tools, and templates


Who should attend?

  • RA manager
  • RA director
  • QA manager
  • QA director
  • International registration department


Costs

We offer open enrolment, on-location, train-the-trainer formats.

Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.

Costs: € 875.- p/p for a one-day training

 

 

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