Risk based test strategy in a medical device industry

Paul Derckx Philips Healthcare MR R&D "Risk based test strategy in a medical device industry"

Regulatory requirements control the development of medical devices and as part of Design Controls the Design Verification shall confirm that the design output meets the design input requirements, or in other words Design Verification has to prove that all (sub)system requirements have been implemented correctly. 

Within Philips Healthcare MRI we follow an ‘evolutionary’ development process, meaning that programs do not develop completely new products/systems, but build further on/add new functionality to the previously released product. In this context parts of the system remain unchanged, raising the question whether or not these parts need to be (re-)verified with each program. With thousands of requirements on system and subsystem level, having to test the product completely with every program would also increase the lead time of Design Verification and thus the programs significantly.

Therefore we have implemented a risk based test strategy where the product/system changes are assessed based on both technical decomposition and the requirements decomposition resulting in the overall test approach for the program.

Paul_Derckx_testdag_2015_keynote_1.pdf