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

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

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