Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often confusing requirement for medical devices.  A fundamental issue is the role reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples. Those who work with process optimization and validation focus on optimizing a process and reducing variability. Those working on Test Method Validation, on the other hand, focus on discerning between process variation and measurement error from the test method itself.

Often, the test method for a new process must be designed specifically for that process, and some of the pitfalls are in confounding the process itself with the test method.  This webinar will present case studies to explore how those issues are addressed.

Although the FDA guides method validation, the Code of Federal Regulations (CFR) Title 21 Part 820: Quality System Regulation (QSR) 21 does not specifically broach the topic of method validation. It alludes to it in equipment qualification, statistical methods, process validation, design controls, and other sections. In numerous warning letters, we have witnessed the significant importance of method validation as an applicable medical device validation activity. Although some traditional methods have been applied to chemical, microbial, and laboratory acceptance testing methods, they are generally less utilized in the medical device industry.

This webinar will help you better understand Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements, and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.

• Test Method Validation - Overview
• Quality System Regulation, 21 CFR Part 820, and ISO 13485 - Overview
• When should Methods be Validated?
• Qualification vs Validation
• Types of Test Method Validations
• How to perform successful test method validations
• How to ensure your inspection of verification is effective
• Detailing real-life case studies
• Understanding global reference standards for test method validation
• FDA requirements for TMV
• How to prove your inspection method is repeatable and reliable
• Recommendations: Some Best Practices and Strategies

Method validation for medical devices can be confusing. The test method must be reliable in detecting defects without rejecting acceptable samples. Process optimization focuses on reducing variability. Designing a test method specific to a new process is crucial to avoid pitfalls. Case studies will be presented to address these issues. FDA guidance is available.