IMDrf Finalizes SaMD Document

The IMDRF Management Committee approved the final N12 document, “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations”. IMDRF publishes their documents at the link provided. This document should be posted in the near future. FDA participates actively in the International Medical Device Regulators Forum (IMDRF) which is seeking to harmonize international regulation.

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

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