Medical Device Validation and Verification

Toltec offers a wide range of independent validation and verification services to help you meet that challenge of complying with FDA's QSR and ISO's 13485 quality system directives. According to the FDA QSR, validation is the "confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled." Verification is "confirmation by examination and provision of objective evidence that specified requirements have been fulfilled." The following are validation and verification services we provide:

Validation and Verification Planning System level Software Mechanical Electrical Process validation Field and/or clinical level

Testing strategy Writing specifications with verification in mind Testing strategies Particular strategies for software integration and test Inspection strategies Use of standards Regression testing, how to manage test failures

Statistical tools

• Determination of proper sample size
• Single sided, double sided criteria
• Normal distributions, other types of distributions, pass/fail tests
• Adjusting stringency based on criticality of the selected parameter
• Development of a statistical procedure for your quality system

Test protocol development for validation and verification

Test execution and documentation of test reports