IEC 62304, the international standard that defines software development life-cycle requirements for medical device software, was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to develop software components. Conformance with this standard demonstrates that there is a software development process in place that fulfills the requirements of the European Union’s Medical Devices Directive 93/42/EEC.

If your medical device has software that regulates its functionality in a way that contributes to basic safety or essential performance, then you’ll need to comply with IEC 62304. This standard requires all aspects of the software development life cycle (SDLC) to be appropriately managed to ensure patient safety, including:
• Development and code reviews
• Risk management
• Configuration management
• Incident and bug resolution
• Validation
• Maintenance

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