Embedded software is the design choice of many manufacturers who wish to implement sophisticated control mechanisms in today's products. Medical devices are not exempt from this trend. Virtually every electrical product we buy contains computer chips and programs that control behavioural aspects of devices; be it cookers, TV remotes, automobiles or toys. Many have experienced a Sky box that locks up or owned a satellite navigation system with nasty quirks that we are promised will be fixed on the next software upgrade. These behaviours are evidence of poor design decisions, mistakes in manufacture, or unanticipated combinations of circumstances which cause the product to malfunction.

All of the above can be true for medical devices; and depending on the nature of the device, may result in an inconvenience, a fatality, or something in between. Reliable software doesn't just happen, nor can extensive testing make up for poor design.

When choosing to embed software as a component of a medical device good design has to be demonstrated. This is very difficult to do after the event, especially in entrepreneurial environments. Priory Analysts have many years of experience of the software development process and can help you to establish the verification procedures (necessary at every step of software development) and the validation of the final product that it is fit for purpose.