Proven Process offers a wide range of independent validation and verification services to help you meet the challenge of complying with U.S. FDA requirements and European Medical Device Directives. Whether it's device design validation, software validation or manufacturing process validation, we ensure that your product meets domestic and international quality standards.

We follow a documented, comprehensive, systematic examination to evaluate the adequacy of the design requirements. Then we implement a risk management process, modeled after ISO 14971, and a verification program to provide objective evidence that your product consistently meets the specified requirements.