SoftComply
What is a Risk Management File?
ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that…
SoftComply
What is Probability of Failure of Medical Device Software?
One of the more controversial requirements of IEC 62304 is the probability of failure of medical…
SoftComply
New Medical Devices Regulation & Risk Management
The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe…