Progressive Roll-out of the In Vitro Diagnostics Medical Device Regulation in Europe (EU IVDR) Progressive Roll-out of the In Vitro Diagnostics Medical Device Regulation in Europe (EU IVDR)Celegence2022-02-23T13:40:58+00:00January 11th, 2022|
Notified Bodies Under EU IVDR Notified Bodies Under EU IVDRCelegence Admin2022-02-23T13:37:08+00:00October 19th, 2021|
Post Market Performance Follow-up Under the IVDR Post Market Performance Follow-up Under the IVDRCelegence2022-02-23T13:40:17+00:00September 28th, 2021|
What is the MDSAP Audit? Guide to MDSAP Audits What is the MDSAP Audit? Guide to MDSAP AuditsCelegence Admin2022-02-23T13:36:00+00:00September 15th, 2021|
What is Performance Evaluation as per the EU-IVDR? What is Performance Evaluation as per the EU-IVDR?Celegence2022-02-23T13:38:28+00:00July 28th, 2021|
EUDAMED – What’s The Fuss About? Guide to EUDAMED EUDAMED – What’s The Fuss About? Guide to EUDAMEDCelegence2022-02-23T13:34:58+00:00July 14th, 2021|
The Impact of the EU IVDR on QMS Requirements The Impact of the EU IVDR on QMS RequirementsCelegence Admin2022-02-23T13:35:48+00:00July 6th, 2021|
Post-Market Clinical Follow-up: End-User Surveys Post-Market Clinical Follow-up: End-User SurveysCelegence2022-02-23T13:39:34+00:00June 23rd, 2021|
How Does the EU IVDR Impact the IVD Industry? EU IVDR Key Changes How Does the EU IVDR Impact the IVD Industry? EU IVDR Key ChangesCelegence Admin2022-02-23T13:34:29+00:00June 16th, 2021|
Impact of Brexit on the Medical Device Industry Impact of Brexit on the Medical Device IndustryCelegence Admin2022-02-23T13:33:31+00:00May 19th, 2021|