Verification & Validation

A medical device engineer at Proven Process Medical DevicesProven 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 medical device meets domestic and international quality standards.

We follow a documented, comprehensive and systematic examination process to evaluate the adequacy of the design requirements. This is followed by a risk management assessment, modeled after ISO 14971, and a verification program to provide objective evidence that your medical device consistently meets specified requirements.