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Tip of the week
Case: Missed mixed status devices in a system
2022, October 9
Tip of the week
Devices that are used together, components, accessories, systems, procedure packs, and the rest…
2022, September 25
Tip of the week
Article 54/59 derogation – yes, it can be done, but I rather suggest you should try not having to depend on it…
2022, September 18
Tip of the week
Recognizing early warnings of approaching problems
2022, September 10
Tip of the week
Check your consistency, your notified body will do that for sure
2022, August 21
Tip of the week
Article 16 – some loose ends in the Regulations…
2022, August 14
Tip of the week
Article 16, where ends the responsibility of the manufacturer?
2022, August 6
Templates and how to’s
How to create a justification for a PRRC
2022, August 2
Tip of the week
UDI in the case of systems and procedure packs
2022, July 30
Tip of the week
The strategic importance of the Basic UDI-DI
2022, July 24
