„To be compliant“ means, in direct translation, to be „corresponding“ or even better, „conforming“ with one’s product. However, conformity implicitly refers to the regulations and guidelines applicable to the product.

Of course, the product should also meet customer requirements, system requirements, and especially performance promises, fulfilling all of these completely.

For medical products, this means complying with the Medical Device Directive, adhering to all applicable and recognized standards, and, of course, passing all tests, verifications, and the final validation demonstrably against the set requirements.

Compliance can only be proven through valid evidence. Therefore, well-documented planning, implementation, testing, and examination are essential.

A central aspect is traceability: all tests must be traceable to requirements in general and always. Conversely, all requirements must also be fully verified and validated.

For certain evidence, „notified bodies“ (e.g., TÜV) must also be consulted. This process is time-consuming and costly, especially if the test fails and the process has to be repeated after a change. Therefore, it is important to know exactly what is required and to gain confidence through so-called „pre-compliance“ tests that the tests can be passed with a high probability.

The path to compliance therefore leads from product specifications through the development process with the defined results, documents, and reviews to verification and validation and ultimately to approval or certification.