Medical devices must be developed in such a way that the result is a safe and functioning product. This is verified by design verification and product validation – as required internationally by regulatory bodies.
Design verification determines whether the product meets the specified requirements.
Product validation determines whether the intended purpose is fulfilled and includes usability.
Design verification and product validation are independent of each other: the product may meet the specified requirements, yet still not fulfill its intended purpose.
The earlier errors are detected, the less effort is required in the form of rework. Verification and validation measures also pay off in the long term, since additonal costs for delayed market launch, recalls or warranty claims are avoided.
Increased product quality and usability contribute significantly to the competitiveness of a product.
Together with you, we develop a targeted strategy for design verification and/or product validation. In this way you can secure rapid market access and competitive advantages.