Medical Devices News & Regulatory Info

Guidance on Addressing Cybersecurity of Connected Medical Devices

Guidance on Addressing Cybersecurity of Connected Medical Devices

Celegence Admin2021-05-11T07:58:43+00:00July 16th, 2020|

Medical Device Labeling Changes and Challenges Under EU MDR

Medical Device Labeling Changes and Challenges Under EU MDR

Celegence Admin2021-05-11T06:34:38+00:00July 6th, 2020|

Components of an Effective Post-Market Surveillance for Medical Devices

Components of an Effective Post-Market Surveillance for Medical Devices

Celegence Admin2021-05-11T08:07:15+00:00July 2nd, 2020|

Remote Medical Audits During COVID-19

Remote Medical Audits During COVID-19

Celegence2021-05-11T08:20:58+00:00June 2nd, 2020|

Addressing the Regulatory Challenges with Software as a Medical Device in EU MDR

Addressing the Regulatory Challenges with Software as a Medical Device in EU MDR

Celegence Admin2021-05-11T08:27:44+00:00May 14th, 2020|

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|

Medical Device Blog

Guidance on Addressing Cybersecurity of Connected Medical Devices

Guidance on Addressing Cybersecurity of Connected Medical Devices

Medical Device Labeling Changes and Challenges Under EU MDR

Medical Device Labeling Changes and Challenges Under EU MDR

Components of an Effective Post-Market Surveillance for Medical Devices

Components of an Effective Post-Market Surveillance for Medical Devices

Remote Medical Audits During COVID-19

Remote Medical Audits During COVID-19

Addressing the Regulatory Challenges with Software as a Medical Device in EU MDR

Addressing the Regulatory Challenges with Software as a Medical Device in EU MDR

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)

Medical Device Resources

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