IEC 62304 software development process

Medical software development is not an easy task. Along with creating a good, functional software for your client, you need to remember about compliance with ISO 13485 as well as IEC 62304. Those regulations aren’t there for nothing – they ensure that the software is safe to use and that the medical devices it will operate will not be faulty in any way. The process of software development is lengthy in itself. If you add all the regulations to the equation, you get a long and tiresome process that without proper planning can be too much. How long does IEC 62304 software development process take and what are the steps that you must remember in order to make it quick and effective?

How long do the ISO and IEC development take?

It is hard to establish one particular time frame for medical software development. Companies must remember that the process is very complicated and the software itself must be compliant to some very strict rules and guidelines provided by the IEC 62304 standard. Previously the requirements for medical device software were not that strict. Now it gets harder and harder as more and more devices rely solely on the software. The time that software development process takes is solely reliant on the company that you outsource the development to, the size of the team that will be dealing with your project and the expertise they have in the particular topic of IEC 62304 compliant software. You can read more about that thread at

IEC 62304 software development process – all the steps

Software development is a lengthy process and it does not, surprisingly, involve coding only. Having to comply with strict rules of the IEC 62304 norm means that there are several steps needed prior to the actual coding part of software development. First of all, there is the development plan stage, where all the requirements and client expectations need to be written down is such a detailed manner that it makes sense to the developers. Those who will actually make the software don’t necessarily know all the requirements word by word – with a plan written down their efficiency is higher and the job gets done much faster.

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Once the plan is written down, the developers are in full working mode. They need to remember about the requirements analysis, architectural draft, detailed draft, coding and verification, integration and testing and system tests. All those are necessary before the release as they all are a way to develop the software with compliance to IEC 62304 and with all the regulations and expectations mentioned in the plan in mind. Particular stages of the development can take almost no time at all or prove to be quite time-consuming, depending on the experience and knowledge of the developers as well as the particular requirements for the software. Some requirements may require new technologies that haven’t been used before. Being innovative is never a quick process. Software for medical devices has to be, above all, safe. That is why the IEC 62304 regulation was created in the first place. When safety comes to play, time isn’t of the essence and the process shouldn’t be rushed.