Product Verification

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

Integration testing:

  • 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.