Location
Helsinki, Finland
Start
03. Oct 2023
9:00 AM
End
03. Oct 2023
4:30 PM
Time Zone
Helsinki, Kyiv, Riga, Sofia, Tallinn, Vilnius (+02:00)
SGS Academy in Finland will organize a training
Technical documentation according to MDR
Date and location:
October 3rd, 2023
9 am – 4:30 pm (Registration and breakfast starting 8.40 am)
Juju Kampus, Takomotie 8, 00380 Helsinki
Introduction:
The European Medical Device Regulation MDR (EU) 745/2017 replaced the Medical Device Directive (MDD) 93/42/EEC from 26 May 2021. The MDR tightens the requirements for medical devices in many respects compared to the directive. For customers of the notified body, one of the most visible changes is that the conformity of technical documents will be evaluated in connection with each audit in the future. This creates a need for manufacturers to increase their expertise in technical documentation requirements, including technical safety, performance and documentation coverage.
The training will be held in Finnish.
Registration:
Please register by September 18th, 2023 at the latest.