verification & validation


Did you design the device the right way? Have you designed the right device?

You can find your answer in the Design Verification and Validation. The purpose of the Verification is to confirm with objective evidences (e.g. Test) that the Design Outputs meet the Design Inputs (Requirements) and that the device has been correctly designed. However, Verification alone cannot guarantee that you have designed the device in the right way; that’s why Validation is needed, which allows you to evaluate whether the device achieves its purpose and meets users’ needs.

Do you need to validate your processes?

Medical device manufacturers must validate any process, including associated equipment and software, the outputs of which cannot be fully verified by simple inspections (e.g. destructive tests) and / or the costs of verifications are too high to justify their use. Process validation allows to establish through objective tests that a process constantly produces a result or a product that meets its predetermined requirements. The result is better repeatability, a reduction of errors, less rework and redesign, faster marketing, greater competitiveness and lower production costs. Process validation is an integral part of the requirements of a QMS. It is conducted in the context of a system that includes design and development control, quality assurance, process control and corrective and preventive actions..

VISPE Medical Device Consulting, VERIFICATION and VALIDATION section, can help you:

  • Define the Design Inputs (Requirements) based on current regulations and following a risk-based approach;
  • Define the strategy to be adopted for carrying out both process and product verification and validation tests (software included);
  • Create the appropriate documentation for each V&V phase (V&V Plan, V&V Report, IQ, OQ and PQ documents);
  • Created and/or implement the Design History File (DHF)

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