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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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