Medical Devices

Medical Devices frequently contain software

• to process images, in which case the software may form a crucial part of a diagnostic system
• to manage a simple display within a hand-held device used to sense and measure a biochemical balance
• as a central component of most electronics-based devices, such as cardiac monitors and pacemakers.

In any event, the software must comply with regulations, which define minimum standards for its development. Clearly, the actual regulatory demands differ according to the nature of the device. Devices that either inject energy or help to control life-critical function must conform to higher standards of design strictness than those which merely record information.

Whilst the tools we use are software based, because of their dynamic nature many aspects are equally relevant in a wider context. For instance, any medical device must be properly specified to enable it to be validated for regulatory approval. Test definitions and hazard analysis must be linked to specification to ensure completeness.

The factors identified in the initial stages of a product's evolution are an integral part of its specification since they provide the benchmarks against which return on investment is assessed. By drawing together strands from marketing, business and technology our high level requirements specifications perform a dual rôle as both a 'technology audit' and the solid foundation for further development.

It is important that development processes are defined and followed. Automating these processes ensures adherence, reduces paperwork and allows production of regulatory documentation as a matter of course.

A medical device must meet a range of regulatory requirements, which define both specific requirements for a class of device and procedural factors that govern the design, development and manufacturing processes. The latter pay especial attention to quality issues that ensure that responsibility for decisions right through the production cycle is clear and can be recovered in a subsequent audit.