Software Risk Management Process in medical devices is an integral part of quality. This fact is recognized by both the FDA and ISO 14971:2007, both of which are formulated on the acknowledgement that there is an element of risk inherent in the use of medical device technology.
It is all about risk reduction
Software Risk Management Process in medical devices is built on the premise that the user’s safety is paramount when using a medical device. That is why Software Risk Management Process in medical devices has the essential goal of reducing product risk. Its other primary goal lies in identifying and understanding the level of risk that remains after this is done, and to assess the impact that this has at this stage on both the user’s safety and the effectiveness of the product.
The role of ISO 14971:2007
So, any medical device company has to implement a robust framework within which it can apply the risk management practices of ISO 14971:2007. The main aim of ISO 14971:2007, a globally accepted standard for medical device safety, is to help medical device companies better the safety and effectiveness of their products while being compliant with regulatory requirements.
Other important requirement
While software Risk Management Process in medical devices has to show compliance with the requirements set out in ISO 14971:2007; Hazard and Risk Analysis documentation is another core requirement of this regulation.
With Hazard and Risk Analysis documentation, device companies should show that they have implemented risk management and risk control processes that can demonstrably and reproducibly be located all the way from the product design right up to its verification and validation records.