Developing software for medical devices is not an easy thing to do. There are so many regulations and requirements that the developers must remember about, it makes the whole medical software development process lengthy and complicated.
Each and every software that hits the medical devices market must be compliant with FDA, EU regulations and international standards such as IEC 62304 and ISO14971. But there are reasons for it to be like this. Software for medical devices must be reliable, valid and as risk-free as possible. So what does it actually take to develop such software? How do developers come about remembering all the requirements and implementing them into the software?
Medical device software – the requirements
Medical device software is audited and controlled by standards defined by FDA, specifically 21 CFR parts 11 and 820. There are also the EU and international requirements that must be met and many verification and validation audits are there to ensure that everything is going smoothly (*1).
Lists of those requirements are, however, long and boring documents that are oddly phrased and difficult to apply. Nevertheless, without full compliance with all the requirements, the software won’t be accepted and valid to use. The FDA classifies medical device software into Class I, Class II and Class III depending on the potential of severity of harm to the patient in the event of a device malfunction.
Medical device software development – the process
Phases of software development lifecycle are described by the ISO 13485 standard – and international regulation that must be followed by all medical software developers (*2). It also sets the standards of conformance for clinical use of the software. This standard works in conjunction with the regulatory aspects of development and is the key set of best practices for device development.
There are four main stages within medical device development. Software proposal and requirements sets the foundations for the device and here all the initial mockups of the product are designed and tested. Also, it’s here where the requirements for the software are generated.
Then there is the design and development stage, followed by software verification and software validation. In the verification process, the developers check if every single regulations has been followed and respected within the software. The validation stage is there to authenticate the efficacy of the software and checking its functionality.
The main difference is that the verification will test the software requirements and the validation will test the design specifications.
With all those complete, the software can go on to be used in medical devices across the world.
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