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Tip of the week
Longread
How to’s
Tip of the week
Longread
How to’s
Tip of the week
Over 1,000 notified body applications per month. Will your device be among them?
2023, May 29
Tip of the week
Regulation (EU) 2023/607 MDR transitional arrangements for Class III and Class IIb, implantable devices
2023, March 24
Tip of the week
Regulation 2023/607 MDR transitional arrangements for Class IIa and Class IIb, non-implantable devices
2023, March 21
Tip of the week
MDR Article 120 and 122 consolidated
2023, March 19
Longread
MDR Amendment Regulation (EU) 2023/607
2023, March 19
Tip of the week
PRRC scenario
2023, February 9
Tip of the week
Feasibility check for the applicability of MDR Article 97
2023, January 4
Tip of the week
Quick due diligence checklist non-integral DDC
2022, December 15
Tip of the week
Quick due diligence checklist integral DDC
2022, December 14
Tip of the week
Drug-device combinations need a specific MD department within a pharma company
2022, December 7
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
Tip of the week
Grouping Device Families: the Basic UDI-DI
2022, July 17
Tip of the week
Avoiding costly mistakes: implement first, develop later
2022, July 11
Tip of the week
CEO’s and General Managers: selecting a PRRC is not a popularity contest
2022, July 4
Tip of the week
Government response to public consultation on the new UK medical devices regulations
2022, June 27
Tip of the week
MDCG’s lifeline for escaping the MDR certification bottleneck
2022, June 15
Tip of the week
The difference between PMS and PMCF in one minute
2022, June 11
Tip of the week
When is UKCA marking necessary?
2022, June 5
Tip of the week
Preparing for UKCA marking of medical devices
2022, June 5
Tip of the week
Justification of product status and risk class
2022, May 22
Tip of the week
Last minute placing on the market under ‘old’ rules
2022, May 15
Longread
Coming soon
2022, May 8
