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.
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