Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
🎤 José Mora | 📅 April 07, 2025 | 🕒 11 AM Eastern Time US
Is Your Test Method Ready for FDA & ISO Scrutiny?
🚀 Are your test methods validated to ensure accuracy and reliability? 🚀 Do you understand the regulatory expectations for TMV compliance? 🚀 Want expert insights on best practices and real-world case studies? This essential training is designed for professionals involved in medical device verification, validation, and quality assurance, including: 👩💻 Research & Development Teams – Ensure new product testing aligns with regulatory standards. 🏭 Quality Assurance & Control Specialists – Strengthen inspection reliability and repeatability. 🛠 Engineering & Manufacturing Teams – Integrate TMV into process development. 📊 Regulatory Affairs Experts – Ensure compliance with FDA, ISO, and GHTF regulations. 💡 Device Development & Design Assurance Professionals – Optimize test methods for product performance verification. Applicable industries: Medical Devices | Biotech | Pharmaceuticals | Life Sciences | Regulatory Compliance |
In the medical device industry, Test Method Validation (TMV) is critical to verifying that your test methods are repeatable, reliable, and effective. However, many organizations struggle with the fine line between process variability and test method variability—leading to unreliable inspections, compliance risks, and potential FDA warnings. The FDA mandates TMV through 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016, yet it remains one of the most misunderstood aspects of validation. How do you ensure your test methods meet global reference standards and regulatory expectations? Join José Mora, a renowned expert in medical device validation with 30+ years of experience, as he provides a practical approach to Test Method Validation (TMV), including real-world case studies, compliance strategies, and best practices for success.
Key Areas Covered:
📌 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
