Software as a medical device

Regulatory failure seems to be fashionable at the moment; from the banks to newspapers, and, it seems, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is also in the firing line. A recent editorial in the Lancet, blames it for failing to properly regulate ‘dodgy’ breast implants from a company called PIP.

It is the MRHA that has recently raised the classification of medical software as a medical device.

 I suspect that with the increasing use of electronic systems in healthcare, and the raised profile of patient safety, then we can expect closer scrutiny of all electronic systems and products.

Fortunately, I believe we (CSC) have a competitive advantage in this area (but then, I’m biased!).