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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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