Verification & Validation of Medical Device Software

To ensure that the developments of 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).

Scope of the Validation and Verification Service

  • 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.

Contact an expert

If you want to know more about the subject or have any other question, do not hesitate, contact us.


ISO 9001

ISO/IEC 27001

ENS-nivel medio

ISO 20000


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