Overview of IEC 62304 for software development life cycle
The standard IEC 62304 (software development life cycle) applies to the development and maintenance of medical device software when:
- The software is itself a medical device.
- Or the software is an embedded or integral part of the final medical device.
IEC 62304 is a functional safety standard that covers safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety.
The nine parts of IEC 62304 are:
Part 1: Scope.
Part 2: Normative references.
Part 3: Terms and definitions.
Part 4: General requirements.
Part 5: Software development process.
Part 6: Software maintenance process.
Part 7: Software risk management process.
Part 8: Software configuration management process.
Part 9: Software problem resolution process.
It’s assumed that you use a quality management system and risk management system.
Annex C documents the relationship to other standards.
The standard also refers to IEC 61508 — the umbrella functional safety standard — as a source for good software development methods, techniques, and tools.
Software safety classification
Software safety classification in the standard determines the safety-related processes you’ll need to use. This impacts the entire software development lifecycle — from requirements and coding to release and maintenance.
The standard defines three safety classes for software:
Class A: No injury or damage to health is possible.
Class B: Injury is possible, but not serious.
Class C: Death or serious injury is possible.
We can help establishing the required documentation for IEC 62304 compliance. We can also work with the software development team to make sure that the compliance is ensured throughout the process. We will work on the integration of the software development life cycle with other components of the quality system such as :
- ISO 13485 — quality management.
- ISO 14971 — risk management.
- EU Medical Device Regulation — EU standard which replaces Medical Devices Directive in 2021.
- FDA regulations — U.S. standards for medical device compliance.
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