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

This course strengthens the ability to distinguish measurement error from actual process variation during medical device test method validation. It supports more reliable inspection decisions, stronger verification evidence, and improved alignment with FDA and ISO quality system expectations. This Course is designed for professionals responsible for validating, verifying, measuring, inspecting, or qualifying medical device processes.

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US $190 per learner

30-Days Unlimited Streaming Access

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To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : José Mora ‎ ‎ 
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3048
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Test method validation presents a unique challenge in medical device manufacturing because the method itself must be evaluated independently from the process or product being measured. A capable process may still produce unreliable inspection outcomes if the test method cannot consistently distinguish acceptable samples from defects. This distinction becomes critical when developing new processes that require custom measurement approaches and where process variation can easily be confused with measurement error.


Regulatory expectations for validation activities continue to place significant emphasis on reliable inspection and verification practices, even though 21 CFR Part 820 does not explicitly define test method validation requirements. FDA warning letters and global quality standards increasingly reflect the importance of validated methods across manufacturing and quality systems. This course addresses practical validation considerations, qualification versus validation decisions, repeatability and reliability expectations, and the application of test method validation principles through detailed medical device case studies.

  • Improved Confidence in Inspection and Verification Results:

    Reliable inspection data depends on understanding whether variability originates from the manufacturing process or from the measurement method itself. This course clarifies how to evaluate repeatability, reliability, and method suitability so validation activities produce dependable verification evidence. These capabilities are increasingly important when supporting inspections, responding to quality observations, or introducing new device manufacturing processes.

  • Stronger Alignment with FDA and Quality System Expectations:

    Medical device organizations continue facing scrutiny around validation practices tied to inspection, verification, and quality system activities. This course explains how test method validation connects with 21 CFR Part 820, ISO 13485, and broader validation expectations. Participants gain practical direction for qualification decisions, method selection, and validation planning using examples drawn from actual medical device manufacturing situations.

Key Areas Covered

  • Distinguishing process variation from measurement error during test method validation
  • Test method validation principles for medical device inspection and verification activities
  • Qualification versus validation decisions and their application within manufacturing and quality systems
  • FDA expectations and validation considerations associated with 21 CFR Part 820 and quality system activities
  • ISO 13485 and global reference standards relevant to test method validation practices
  • Approaches for establishing repeatability, reliability, and effective inspection methods
  • Common pitfalls when developing validation methods for new manufacturing processes
  • Real-life medical device case studies illustrating practical validation and verification challenges

Who Must Attend

  • QA/QC Departments
  • Research & Development Teams
  • Engineering Departments
  • Regulatory Affairs Departments
  • Operations Departments
  • Documentation Departments

Quality training, expert insights, and answers that matter. Know your Expert

JOSÉ MORA

José Mora is a Principal Consultant specializing in manufacturing engineering and quality systems within the medical device industry. His experience includes process development, tooling qualification, manufacturing operations, and quality system implementation across catheter systems, surgical instruments, orthopaedic devices, implants, and vascular products. He has led process validation, manufacturing re-engineering, and quality improvement initiatives at organizations including Boston Scientific, Stryker Orthopedics, Cordis Corporation, and medical device start-up operations focused on regulated manufacturing environments.

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Our students love us ❤️

“Covered several points we have recently been discussing internally around inspection consistency. Easy to connect with day-to-day work.”

Supervisor, Operations Department

“Good pace throughout the presentation. The material was clear and easy to follow.”


Associate, Manufacturing Department

“Presenter used practical examples throughout. That made the discussion easier to connect with.”

Engineering Department

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