EU Borderline and Classifcation Committee SW group

The European Commission Borderline and Classification committee has put out a call for software experts to join a working group on qualification and classification of software. The first meeting will be December 2nd, and will be chaired by Lennart Philipson from the Swedish Medical Products Agency. The Medical Information System report from Sweden has been circulated as a starting point. See the report at the link provided. This, as well as other EU activities related to changes in wording in the device directives related to software and Health Canada’s recent reclassification of patient information systems, indicates increased focus on healthcare information systems and standalone software.

Medical Information Systems Report 2009

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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