The requirements definition is the foundation of any medical device design project; and when you work with KMC Systems, this equals system performance, cost-effectiveness, and end-user satisfaction.
We closely coordinate the development of the systems requirements with the software requirements and risk management process activities. This leads to mechanical, electrical, and software functionality.
From the system level, we drill down to the module level requirements and medical device design documents. This ensures all details necessary to meeting the requirements are documented, including
- operating principles
- design rationale