Verification & Validation of Medical Device Software

To ensure that the developments carried out in your company are carried out with the quality you expect:

We provide independent verification and validation services for medical device software in accordance with applicable regulations, both for Europe (CE marking, MDR/IVDR) and for the United States (FDA).

Alcance del proceso de verificación y validación

Development of the Validation and Verification Plan.
Execution of the Validation and Verification Plan.
Reporting of results including traceability matrix between requirements and tests.
Formal documentation reviews.
Code reviews.
Unit and integration testing.
Functional and acceptance testing.
Static and dynamic methods.
Implementation of quality and safety standards.
Training of client personnel.