Verification and validation of a medical device is crucial to achieve compliance. The verification determines whether or not a system or product meets all specified requirements. Verification also examines test readiness, for example, if all requirements are included in the test cases.
Validation determines whether or not the system achieves its intended use and the specified functional and performance requirements are met.
We provide experienced expert consultants to support you with:
Planning of V&V activities, preferably based on the outcome of the risk assessment of a product or service.
Execution of a verification and validation activities, both as leaders and hands on.
V&V documentation compilation.
Implementation of tools supporting V&V activities, traceability and documentation.
Contact me for further information Robert Ginsberg
Office +46 8 621 01 05 or send me an mail