Medical Devices News & Regulatory Info

Implications of COVID-19 on the Medical Device and Diagnostics Industry

Implications of COVID-19 on the Medical Device and Diagnostics Industry

Celegence Admin2021-05-11T08:30:22+00:00April 22nd, 2020|

IMDRF & Summary of Recent Changes to Clinical Evaluation Guidance

IMDRF & Summary of Recent Changes to Clinical Evaluation Guidance

Celegence Admin2021-07-07T04:57:50+00:00April 16th, 2020|

Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)

Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)

Celegence2024-09-05T15:55:23+00:00April 1st, 2020|

FDA Medical Device Registrations – 510(k) Submissions

FDA Medical Device Registrations – 510(k) Submissions

Celegence2021-05-11T08:47:29+00:00March 25th, 2020|

Medical Devices with Ancillary Medicinal Substances (Combination Products)

Medical Devices with Ancillary Medicinal Substances (Combination Products)

Celegence2021-05-11T09:22:13+00:00March 11th, 2020|

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|

Medical Device Blog

Implications of COVID-19 on the Medical Device and Diagnostics Industry

Implications of COVID-19 on the Medical Device and Diagnostics Industry

IMDRF & Summary of Recent Changes to Clinical Evaluation Guidance

IMDRF & Summary of Recent Changes to Clinical Evaluation Guidance

Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)

Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)

FDA Medical Device Registrations – 510(k) Submissions

FDA Medical Device Registrations – 510(k) Submissions

Medical Devices with Ancillary Medicinal Substances (Combination Products)

Medical Devices with Ancillary Medicinal Substances (Combination Products)

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

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

Selecting and Working With Your Notified Body for Entering European Market

Selecting and Working With Your Notified Body for Entering European Market

Brexit Changes to the Regulatory Process for the Life Sciences Industry

Brexit Changes to the Regulatory Process for the Life Sciences Industry

Medical Devices: Low-Risk Device Challenges MDR

Medical Devices: Low-Risk Device Challenges MDR

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

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

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