Proposed Final Document: Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions
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: Change Management to Registered Medical Devices
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Change Management to Registered Medical Devices will be proceeded for endorsement at The GHWP 28th Annual Meeting.
Proposed Final Document: Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative
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
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.