Newselena2024-09-18T14:25:57+00:00

Medical Device Blog

The latest global news and insights of the medical devices industry from our expert global team.

EU MDR Checklist – Key Timelines & Impact on Medical Device Companies

EU MDR Checklist – Key Timelines & Impact on Medical Device Companies

Celegence2021-05-11T07:04:54+00:00February 13th, 2020|

Selecting and Working With Your Notified Body for Entering European Market

Selecting and Working With Your Notified Body for Entering European Market

Celegence Admin2021-05-11T09:42:00+00:00January 23rd, 2020|

Brexit Changes to the Regulatory Process for the Life Sciences Industry

Brexit Changes to the Regulatory Process for the Life Sciences Industry

Celegence2021-02-09T16:31:51+00:00January 15th, 2020|

Medical Devices: Low-Risk Device Challenges MDR

Medical Devices: Low-Risk Device Challenges MDR

Celegence2021-05-11T10:01:44+00:00January 8th, 2020|

Post-Market Clinical Follow-up (PMCF) Requirements under the EU MDR

Post-Market Clinical Follow-up (PMCF) Requirements under the EU MDR

Celegence2021-05-07T09:17:44+00:00April 24th, 2019|

The New European Union MDR: Impact on Technical Files

The New European Union MDR: Impact on Technical Files

Celegence2021-05-11T10:13:30+00:00September 21st, 2018|

Medical Devices: Substantial Equivalence vs. Demonstration of Equivalence

Medical Devices: Substantial Equivalence vs. Demonstration of Equivalence

Celegence2021-05-11T10:17:00+00:00July 25th, 2018|