Proposed Final Document: Guidance on the Risk-Based Approach to Quality Management System Aspects: ISO 13485:2016

Submitted by admin on Tue, 11/28/2023 - 19:29

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidance on the Risk-Based Approach to Quality Management System Aspects: ISO 13485:2016 will be proceeded for endorsement at The GHWP 27th Annual Meeting.

Proposed Final Document: Guidance for Additional Considerations to Support Conformity Assessment of In vitro Companion Diagnostic Medical Devices

Submitted by admin on Mon, 11/27/2023 - 20:21

 

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidance for Additional Considerations to Support Conformity Assessment of In vitro Companion Diagnostic Medical Devices will be proceeded for endorsement at The GHWP 27th Annual Meeting.

Proposed Final Document: A Guide to Understanding Best Practices in Audit Life Cycle Management

Submitted by admin on Mon, 11/27/2023 - 19:57

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: A Guide to Understanding Best Practices in Audit Life Cycle Management will be proceeded for endorsement at The GHWP 27th Annual Meeting.