While medical software development experts will be familiar with this process standard, other professionals in the biopharma and medtech space may not know much about it. In order to understand its relevance, you should consider the similarly named IEC 62304, which stipulates how software developers should develop, release, and maintain health software, whether it’s part of a medical device or comprises the device itself. IEC 62304 defines the activities that must be conducted and the documentation that needs to be produced in order to deliver safe, reliable medical software.
IEC 82304 builds on this foundation and establishes additional best practices specifically for software-only medical devices (such as an app that helps monitor your blood pressure) and software-only products for other health uses (such as a fitness-tracking app). The goal is to produce software that users can count on.
IEC 82304 helps companies creating safe digital health solutions that meet patient/user needs by:
There are some nuances with this standard. IEC 82304 is not well known in the industry, and it’s not yet widely applied. This type of standard isn’t mandatory, and regulatory bodies aren’t specifically asking for compliance with this standard yet. But if your platform doesn’t adhere to standards like IEC 82304, it will be a lot harder to prove that your product is safe and effective.
What does IEC 82304 look like in action?
IEC 82304 is a process standard, meaning it dictates the process you should follow when developing software. There are countless ways to create software, so process standards focus on the process rather than the product. This particular standard is concerned with the documentation and activities that are necessary to create reliable health software.
BrightInsight goes through a user requirement capturing phase, then defines the software requirements and architecture, and specifies the design before writing new software. Once the software is written, it goes through a series of testing steps that start at the most detailed level and then build up from there, integrating components of the software that are then tested until we have a complete product. Then we launch validation tests to ensure the product works the way the customer expects it to work.
We believe that you can’t test safety into software once it’s finished. You have to design safety in from the start, and test it iteratively to make sure the software really is as safe as you aim for it to be. With IEC 82304 as a guideline, we are able to design, test, verify and validate best-in-class medical software.
While regulatory bodies don’t yet require this process standard, the users are the ones who demand consistency across development, and BrightInsight complies with IEC 82304 in order to meet that expectation. From establishment of the intended use of a new health software to validation and maintenance, we strive to provide the best possible software-only medical devices and products for health uses.