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

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

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