Development plan versus development process

Medical device manufacturers are obliged to both describe the development process and create a development plan. Because both documents specify how medical devices will be developed, there is uncertainty as to which information belongs in which document. This article resolves this and also examines the software. It looks at the software development plan and the…

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Development process: Lean and compliant with standards

Laws and standards formulate requirements on how medical device manufacturers must define and document the development process. Notified bodies check these requirements during audits. This article on the development process provides tips on how to design the process and how to align it with other processes, such as the risk management process.

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Probability of software defects

The probability of software defects is difficult to estimate. It’s so difficult that the “old” DIN EN IEC 62304:2006 wrote: “However, there is no agreement on how to determine the probability of the occurrence of software failures using traditional statistical methods.” The standard concluded that “the probability of such a malfunction must be assumed to…

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Finally understandable: use scenario – user story – user task

IEC 62366-1 uses the concept of (hazard-related) use scenario. The FDA uses the concept of critical (user) tasks. In development, one works with use cases and user stories. This diversity of terms makes a common understanding difficult. However, this is necessary to create consistent and legally compliant usability files and to avoid regulatory problems. This…

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