Standards Update – 82304, 80002-2, 80001-2-9 Software

Although IEC 82304-1 Health Software: General requirements for safety has been published it is not clear when it will be harmonized in the EU. Nonetheless it appears EU notified bodies are treating it as “state-of-the-art” and are likely to expect it to be used for software products that are regulated as medical devices.

IEC TR 80002-2 Medical device software – Part 2: Validation of software for medical device quality systems is expected to be published shortly.  This Technical Report (TR) provides guidance for new requirements in ISO 13485:2016 for validating software used in quality systems.

IEC 80001-2-9 Application of risk management for IT-networks incorporating medical devices – Part 2-9: Application guidance – Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities 80001-2-9 has been published.  This TR shows how a security assurance case can be used to demonstrate confidence that 80001-2-2 security capabilities have been achieved.

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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