Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
The document herein was produced by the International Medical Device Regulators Forum (IMDRF),
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The document herein was produced by the International Medical Device Regulators Forum (IMDRF),
This document is inscribed in the framework of the International Medical Device Regulators Forum (IMDRF).
This document was produced by the International Medical Device Regulators Forum.
Title: Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations
on in vitro diagnostic medical devices
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