scrutinizing-test-method-validation-tmv-to-verify-the-performance-of-a-medical-device

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

Live Webinar

  • 60 minutes

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. Join this session by expert speaker José Mora, where he will present case-studies to explore how those issues are addressed.

Session Highlights:

  • 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

Why You Should Attend:

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.

Who Should Attend:

  • Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

  • Research & Development

  • Quality Engineers and Auditors

  • Manufacturing Engineers

  • Regulatory Affairs Teams

  • Quality Assurance & Quality Control Teams

  • Operations Teams

  • Document Control

  • Design Assurance Teams

  • Device Development Teams

  • Personnel involved in Verification and Validation planning, execution and documentation for devices


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Jose Mora

Jose Mora

Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.

During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa's business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis' first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.

During his time at Cordis, Jose managed the Maintenance and Facilities Department, taking that operation to a level rated as "tops" by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose's leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.

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