Proposed Final Document: Comparison study of ISO 13485 vs. QMS requirements in GHWP member countries or regions

Submitted by admin on Fri, 12/06/2024 - 11:41

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Comparison study of ISO 13485 vs. QMS requirements in GHWP member countries or regions will be proceeded for endorsement at The GHWP 28th Annual Meeting.

Proposed Final Document: Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions

Submitted by admin on Fri, 12/06/2024 - 11:40

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions will be proceeded for endorsement a

Proposed Final Document: Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative

Submitted by admin on Fri, 12/06/2024 - 04:56

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative will be proceeded for endorsement at The GHWP 28th Annual Meeting.

Proposed Final Document: Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative

Submitted by admin on Fri, 12/06/2024 - 04:10

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative will be proceeded for endorsement at The GHWP 28th Annual Meeting.