Speaker: Bjarne Månsson
Venue: Copenhagen (May 21st 2014)
A basic design input to the development of safety related devices (like medical devices) is a risk analysis which shall identify possible unintended misuse and harm to the user when using a safety related device. Mitigations suggest means in the product design, which will minimize the risk when using the device.
Designing safety related devices is based on risk analysis in order to convince authorities of the safe use of the device. If the launched product fails anyway, it will surely lead to a mandatory recall from the market. In order to prove process maturity to the authorities, it is mandatory to apply systems for requirement management and for configuration management. The testing activities are part of the management systems.
Some examples of FDA (Food and Drug Administration) recalls from the American market will illustrate the seriousness of designing medical devices.