Software development process, although different for various industry fields, generally follows one and the same flow. However, with software entering into the world of science and medical devices, some changes had to be made.
Software for medical devices is crucial for ensuring safety of the devices and as such, it must be compliant to ISO 13485 standards like any other component of the device would. Developing such software is not an easy process and ISO 13485 works in conjunction with the regulatory aspects of software development to set forth a foundation of best practices for developers all over the world. How does software development work in the world of science? What are the stages within medical device software development?
Software proposal and requirements
The first step to get the software going is to design a mockup of the product, shape product concepts, develop prototypes and receive feedback from clinical and user trials. Documentation for this phase is minimal, because it’s just the beginning and with the restrictive nature of ISO 13485, full documentation will be prepared later on. This stage is also the first formal project phase, in which requirements for the software are generated through brainstorming sessions with the marketing group and the clinicians.
Software design and development
At this point all the requirements that were agreed upon in the first stage need to be implemented into the software. This can include software architecture, unified modelling language (UMI) diagrams and use case scenarios to meet the product specifications, e.g. information security. These elements make up the design specification document and will have a review and approval processes as part of a formal phase gate review. Once the documentation and design are ready, the software can be built and implemented based on the specifications. Accurate revision history logs are required to be maintained alongside detailed feature and quality assurance tracking.
The change history logs are necessary according to ISO 13485 requirements and will come in handy in case there is a need to revert to previous version of the software.
Software verification and validation
When all is designed and functioning, it’s time to verify it. The verification stage involves checking the functional form of all software developed and there are specific software verification checklists and protocols to go by. The software has to be once again verified against the ISO standards as well as FDA standards. All in the name of the safety of a medical device. After all, each and every component of the device has to comply to the standards and software is just another one of those.