IEC 80002-1 and 80001-1 reconfirmed to 2016

IEC 80002-1 “Guidance on the application of ISO 14971 to medical device software” has been reconfirmed with a new stability date of 2016. This means that the document will not change before 2016. The next review to determine if the technical report should be revised will occur in 2015.

IEC 80001-1 “Application of risk management for IT-networks incorporating medical devices” has been reconfirmed for one year with a new stability date of 2016. Revision of this standard will begin in 2014.

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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