IMDRF Standalone SW QMS Guidance

A new International Medical Device Regulators Forum (IMDRF) document was finalized.  It is Software as a Medical Device (SaMD): Application of Quality Management System.  The objective of the document is to provide guidance on the application of existing standardized and generally accepted QMS practices to SaMD.

View the document at this link:  imdrf-tech-151002-samd-qms

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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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