Medical Devices News & Regulatory Info

Post Market Performance Follow-up Under the IVDR

Post Market Performance Follow-up Under the IVDR

Celegence2022-02-23T13:40:17+00:00September 28th, 2021|

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Q&A

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Q&A

Celegence2024-02-14T06:15:21+00:00September 22nd, 2021|

What is the MDSAP Audit? Guide to MDSAP Audits

What is the MDSAP Audit? Guide to MDSAP Audits

Celegence Admin2022-02-23T13:36:00+00:00September 15th, 2021|

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Part 2

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Part 2

Celegence2024-02-14T06:15:57+00:00August 5th, 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|

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Part 1

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Part 1

Celegence Admin2024-02-14T06:16:06+00:00July 21st, 2021|

EUDAMED – What’s The Fuss About? Guide to EUDAMED

EUDAMED – What’s The Fuss About? Guide to EUDAMED

Celegence2022-02-23T13:34:58+00:00July 14th, 2021|

The Impact of the EU IVDR on QMS Requirements

The Impact of the EU IVDR on QMS Requirements

Celegence Admin2022-02-23T13:35:48+00:00July 6th, 2021|

Best Practices for UDI Implementation and EUDAMED Submissions – Q & A

Best Practices for UDI Implementation and EUDAMED Submissions – Q & A

Celegence Admin2024-02-14T06:18:56+00:00June 29th, 2021|

Post-Market Clinical Follow-up: End-User Surveys

Post-Market Clinical Follow-up: End-User Surveys

Celegence2024-09-19T14:52:18+00:00June 23rd, 2021|

Medical Device Blog

Post Market Performance Follow-up Under the IVDR

Post Market Performance Follow-up Under the IVDR

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Q&A

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Q&A

What is the MDSAP Audit? Guide to MDSAP Audits

What is the MDSAP Audit? Guide to MDSAP Audits

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Part 2

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Part 2

What is Performance Evaluation as per the EU-IVDR?

What is Performance Evaluation as per the EU-IVDR?

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Part 1

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 – Transcript – Part 1

EUDAMED – What’s The Fuss About? Guide to EUDAMED

EUDAMED – What’s The Fuss About? Guide to EUDAMED

The Impact of the EU IVDR on QMS Requirements

The Impact of the EU IVDR on QMS Requirements

Best Practices for UDI Implementation and EUDAMED Submissions – Q & A

Best Practices for UDI Implementation and EUDAMED Submissions – Q & A

Post-Market Clinical Follow-up: End-User Surveys

Post-Market Clinical Follow-up: End-User Surveys

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