As already mentioned, medical device verification is often done at sub-system / module level and often in parallel with the design and development phases. It requires the availability of the specifications and of testing procedures / methods.
The verification includes tests, inspections and analysis on the various layers and sub-systems of the product.
Testing at module level
It implies the verification that each module / subsystem is correctly operating according to its agreed specification. In addition to the performance testing, the verification will include:
- Environmental testing,
- Safety testing,
- Reliability demonstration,
- Compliance with standards
These tests anticipate the equivalent tests done at system level and could prevent the use of modules / subsystems evidencing already some criticalities.
For software-based modules the tests will imply the verification of the specification at the SW program’s smallest component running independently.
Testing at system level
- the various modules are integrated with each other and tested to assure that they work together;
- the software is merged with the hardware and the whole system is tested to verify its correct operation;
Compliance with the product’s technical specifications:
Verification that the system addresses the system specifications.