IEC 62304:2015 defines the software life cycle processes for medical devices, covering development and verification across safety classes A to C. It specifies tool planning requirements in section 5.1.4 and outlines qualification criteria for Class C tools in Annex C.7, referencing IEC 61508. QA Systems tools are widely used in medical device development, supporting coding standards like MISRA, CERT, and CWE. Cantata, Cantata Hybrid, and QA‑MISRA have been certified by SGS‑TÜV Saar GmbH as class T2 offline support tools under IEC 61508 Part 3, making them suitable for verifying safety‑critical medical software up to the highest classification.

Join for free to read