Medical software and devices that utilize software now require compliance to IEC 62304.
This includes not only devices that require compliance to IEC 60601-1 but also 61010-1 safety standards, and devices which require FDA pre market submissions.
The IEC 62304 standard focuses on the software development process and defines the typical activities of the software development life cycle such as planning, risk analysis and mitigation, requirements analysis, design, implementation, use of pre-existing software (SOUP / COTS), verification/testing and release.
Implementing a software development process that utilizes 62304 does not have to create an overly burdensome process!!
The key is designing a software development process that results in more robust and safe software, and creates the required trace elements of IEC 62304 as an output.
The process does not exclude the use of an agile process, and can form the back bone of a robust agile process.
