Menu
- Update MDSAP Audit Approach MDSAP AU P0002.007
- MDCG 2022-05 Guideline on borderline products
- The importance of the device label to a global UDI system
- SGS Belgium NV 25th Notified Body MDR
- MDCG 2021-26 Q&A on repackaging & relabelling activities
- New MDCG guidance document MDCG 2021-24
- TUV Rheinland Italia designated Notified Body MDR
- MDCG 2021-13 rev.1
- Rob Udo as of now freelance trainer Mikrocentrum
- DEKRA Certification BV Notified Body for IVDR
- Technical Boards of CEN and CENELEC accepted standardization request
- Update references of harmonised standards for medical devices
- MDCG 2021-3 Questions and Answers on Custom-Made Devices (MDR)
- MDCG 2021-1 guidance during the absence of EUDAMED
- Revision standard and guidance Risk Management Medical Devices
- Remote Notified Body Audits possible for MDR and IVDR
- Position paper for the interpretation of device related changes
- Regulating medical devices from 1 January 2021
- Eudamed launched with actor registration module live
- Embracing remote audits
- How to register your company in EUDAMED?
- New document MDSAP audit approach
- ISO 14155:2020 Clinical investigation medical devices for human
- COVID exception medical devices expires
- DQS is 16th Notified Body MDR
- MDCG 2020-13 clinical evaluation assessment report
- ISO/TR 24971:2020 Guidance on the application of ISO 14971
- EC publishes new version of Manufacturer's Incident Report
- MDR Date of Application 26 May 2021
- Update harmonized standards for MDD & IVD directives
- Will MDR be postponed for a year?
- MDCG Offers MDR Implementation Plan, ‘Significant Change’ Guidance
- NSAI 11th Notified Body MDR
- "Worst case scenario" MDR and MDD realistic for third countries?
- MDCG 2019-15 Guidance Notes Class I Medical Devices
- DEKRA Certification B.V. designated under MDR
- MDCG 2019-11 Software classification in the MDR and IVDR
- TÜV Rheinland 5th Notified Body MDR
- US asked to push back the deadline for the new EU MDR requirements.
- Worlds first MDR certificate issued by BSI
- DEKRA Germany 3rd NoBO under MDR
- LRQA dropping out as Notified Body
- Virtual Manufacturing of Medical Devices
- MDSAP Qualified Auditor
- GDPR compliant
- Health Canada modifies MDSAP transition process
- FAQ transition timelines MDR/IVDR
- MDR/IVDR roadmap published
- Human Factors and Usability Engineering
- Interactive guidance MHRA
- Standard development
- MDR / IVDR approved
- EU MDR / IVDR publication close
- ISO13485:2016 published
- Final text MDR /IVDR for voting