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Important steps of IEC 62304-compliant software development process

Companies and software development houses engaged in medical device software development are required to comply with a set of medical device standards as well as other regulations before the device itself can be marketed. Among those standards is IEC 62304, which was designed specifically for medical device software. It describes the software life-cycle processes and defines the processes that are required in order to develop software that is safe and ready to use. However, the standard only says what to do – it doesn’t say how to do so. The lack of a structured plan template for IEC implementation is proving to be more and more visible and companies are constantly looking for a good example of how to implement the IEC standard. What are the most important steps of IEC 62304 that must be followed in the process of developing medical device software?

Software development planning

The software development planning stage is arguably the one that you should never skip if you wish to make the IEC 62304 compliant software. It details methods that will be used and approaches that will be followed for each activity and element of the development process. At this stage, it should be determined what software requirements does the client have and which are required by the IEC 62304 standard. They should all be included in the software development plan and at each development stage, they should be revised in order to keep everything safe and complaint. Remember to keep documentation for every stage and the level of detail should be sufficient to give the developers full guidance. The plan should reference specific standards, methods, tools, actions etc. It should also include all safety and security measures that are necessary for the whole process to comply with IEC 62304 rules.

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Software architectural design

Once the planning is done and all requirements are written down, it’s time to actually design the software. The design sees software as an architecture as well as looks into details of the project. IEC 62304 describes the life-cycle processes and the processes that are required for the software to be safe and ready to use in minute detail. Developers are not required to know all the intricacies of the regulation – all of those should be written down for them in the plan so that they can actually design the software according to the requirements. It is always good to seek for further information from professionals (further read about ISO and IEC implementation is available at

Software verification, integration, and testing

It should be obvious by now that the software development process for IEC 62304 compliant software is very detailed and immaculate. As such, it is destined to be lengthy and very repetitive. The developers need to put the software through a series of tests that will make sure the software is actually viable and compliant with all the requirements. If it is, it goes into the next stage – the verification. By now the software should be tested for any possible imperfections and they should have been already fixed. If it is, it goes to trial by verification bodies that make sure the software will not cause harm by faulty operating devices.