Verification & Validation

Proven Process Medical Devices offers a wide range of independent validation and verification services to help you meet the challenge of complying with FDA requirements and EU medical device, active implantable medical device, and in-vitro 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.