Test Method Validation (TMV)

ViVitro Labs offers contract testing services to device manufacturers and research organizations using recognized or unrecognized methods (e.g. developed internally by ViVitro Labs) and equipment for regulatory and non-regulatory purposes. According to ISO 17025 clause 7.2.2.1 “The laboratory shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified.” In addition, more and more regulatory bodies around the world require test methods to be validated for their intended purpose. During regulatory submission or during site audits, often device manufacturers must provide sufficient objective evidence to show that test data was generated with validated test methods. Test Method Validation (TMV) refers to a systematic and documented process of confirming that a specific test method is suitable for its intended purpose and meets certain established criteria for accuracy, precision, reliability, and repeatability.

According to ISO 17025, the techniques used for Test Method Validation can be one of, or a combination of, the following:

  • Calibration or evaluation of bias and precision using reference standards or reference materials.
  • Systematic assessment of the factors influencing the result
  • Testing method robustness through variation of controlled parameters
  • Comparison of results achieved with other validated methods.
  • Interlaboratory comparisons.
  • Evaluation of measurement uncertainty of the results based on an understanding of the theoretical principles of the method and practical experience of the performance of the test method

ViVitro Labs (Marseille and Victoria locations) has ISO/IEC 17025:2017 accreditation with A2LA for defined methods and parameters. Test Operating Procedures (TOPs) and test equipment must be validated in order to be included in the scope of our ISO/IEC 17025:2017 certificate. (Refer to ViVitro Labs scope of accreditation on the A2LA website for accredited methods and parameters – Marseille and Victoria locations). Contract testing services conducted under our Full Service Level (FLL) are generally used for regulatory submission and must use validated test methods. ViVitro Labs works in partnership with cardiovascular device manufacturers to validate specific test methods used for either V&V studies or QA inspection. Our customer benefit directly from the high quality Test Method Validation process and techniques that ViVitro Labs has developed to comply with internal requirements (Check with your local representative for other test methods undergoing validation).

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