Regulated medical device software needs to do more than work at release. It needs to remain understandable, verifiable and defensible as requirements change, architectures evolve, cybersecurity risks emerge and new versions are developed.
The challenge is knowing how much engineering and lifecycle rigour is needed, when it is needed, and how to apply it without creating unnecessary friction.
In this guide, we explore how engineering teams can build the technical foundations needed to develop regulated medical software capable of evolving without losing control of safety, verification or regulatory evidence.
Key challenges explored:
- Balancing development speed and lifecycle rigour at different stages of a regulated software programme
- Designing software with verification and traceability in mind from the outset
- Maintaining confidence when requirements, risks and software change
- Addressing engineering risk at the interfaces and system boundaries
- Managing cybersecurity as a lifecycle concern
- Involving external partners in software development
