Medical Devices News & Regulatory Info

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 Changes

Celegence Admin2022-02-23T13:34:29+00:00June 16th, 2021|

Best Practices for UDI Implementation and EUDAMED Submissions – Sharma’s Presentation

Best Practices for UDI Implementation and EUDAMED Submissions – Sharma’s Presentation

Celegence2024-02-14T06:20:00+00:00June 10th, 2021|

Best Practices for UDI Implementation and EUDAMED Submissions – Dr. John Bradsher’s Presentation

Best Practices for UDI Implementation and EUDAMED Submissions – Dr. John Bradsher’s Presentation

Celegence2024-02-14T06:21:06+00:00May 27th, 2021|

Impact of Brexit on the Medical Device Industry

Impact of Brexit on the Medical Device Industry

Celegence Admin2022-02-23T13:33:31+00:00May 19th, 2021|

Guidance for Outsourcing Your Organization’s Medical Device Regulatory Activities

Guidance for Outsourcing Your Organization’s Medical Device Regulatory Activities

Celegence2022-02-23T13:37:38+00:00May 12th, 2021|

Medical Device Approvals – FDA Vs EU MDR

Medical Device Approvals – FDA Vs EU MDR

Celegence2022-02-23T13:36:28+00:00March 10th, 2021|

Approach to Authoring a Clinical Evaluation Report Under the EU MDR

Approach to Authoring a Clinical Evaluation Report Under the EU MDR

Celegence Admin2022-02-23T13:27:13+00:00February 25th, 2021|

Clinical Evaluation Report – Introduction to Clinical Reports

Clinical Evaluation Report – Introduction to Clinical Reports

Celegence2021-05-11T07:25:48+00:00February 3rd, 2021|

Why Software as a Medical Device (SaMD) is Prioritized in the EU MDR – Industry Perspective

Why Software as a Medical Device (SaMD) is Prioritized in the EU MDR – Industry Perspective

Celegence Admin2021-09-16T18:04:22+00:00January 12th, 2021|

Clinical Evaluations for Unique Product Types Under the EU MDR – Q&A

Clinical Evaluations for Unique Product Types Under the EU MDR – Q&A

Celegence Admin2024-02-14T06:24:11+00:00January 4th, 2021|

Medical Device Blog

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 Changes

Best Practices for UDI Implementation and EUDAMED Submissions – Sharma’s Presentation

Best Practices for UDI Implementation and EUDAMED Submissions – Sharma’s Presentation

Best Practices for UDI Implementation and EUDAMED Submissions – Dr. John Bradsher’s Presentation

Best Practices for UDI Implementation and EUDAMED Submissions – Dr. John Bradsher’s Presentation

Impact of Brexit on the Medical Device Industry

Impact of Brexit on the Medical Device Industry

Guidance for Outsourcing Your Organization’s Medical Device Regulatory Activities

Guidance for Outsourcing Your Organization’s Medical Device Regulatory Activities

Medical Device Approvals – FDA Vs EU MDR

Medical Device Approvals – FDA Vs EU MDR

Approach to Authoring a Clinical Evaluation Report Under the EU MDR

Approach to Authoring a Clinical Evaluation Report Under the EU MDR

Clinical Evaluation Report – Introduction to Clinical Reports

Clinical Evaluation Report – Introduction to Clinical Reports

Why Software as a Medical Device (SaMD) is Prioritized in the EU MDR – Industry Perspective

Why Software as a Medical Device (SaMD) is Prioritized in the EU MDR – Industry Perspective

Clinical Evaluations for Unique Product Types Under the EU MDR – Q&A

Clinical Evaluations for Unique Product Types Under the EU MDR – Q&A

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