Risk Management is an area that is attracting more interest, particularly in the area of Medical Devices, where the concept of risk can be described as having two components: the probability of occurrence of harm, and the potential severity of that harm if it were to occur.

Increasing attention is being paid to the means by which manufacturers of Medical Devices and IVDs are evaluating and managing risk with respect to products that they place on the market.

Pre and post launch, the means by which Risk Management procedures are integrated with other key Quality System procedures, such as CAPA Management, is important for organizations to consider, in order to be able to demonstrate consistency of approach with respect to the evaluation of specific hazard severities and probabilities of occurrence.

We have actively worked in these areas with a number of clients and can provide support, from giving general guidance to writing procedures and delivering training.