Test Method Validation (TMV) 2025

See details

4.9 out of 5

22 votes

The document provides a comprehensive guide on Test Method Validation (TMV) specifically for the medical device industry. It outlines the objectives, processes, and best practices necessary to plan, execute, and document TMV activities to ensure compliance with validation requirements. The authors, Mai Nguyen-Misra and George Omae from Medtronic, emphasize the importance of demonstrating that test methods are suitable for their intended purpose and capable of producing valid results. The document includes sections on TMV overview, types, process flow, maintaining validated states, and a case study illustrating practical application.

Here's how it works

01. Edit your tmv medical device online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send test method validation for medical devices pdf via email, link, or fax. You can also download it, export it or print it out.

How to use or fill out Test Method Validation (TMV) with our platform

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Click ‘Get Form’ to open the Test Method Validation (TMV) document in the editor.
Begin with Section 1, which provides an overview of TMV. Fill in your organization's specific details regarding the purpose and benefits of TMV.
Proceed to Section 2, where you will document your case study. Ensure you include all necessary prerequisites and validation levels based on risk assessment.
In the execution phase, detail each step of your validation process, including roles and responsibilities. Use tables or flowcharts for clarity.
Finally, review your documentation for completeness and compliance. Attach any supporting data or references as needed before saving your work.

Start using our platform today to streamline your Test Method Validation process for free!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is the test method validation?

Test methods are the set of procedures defined to execute the tests. Test Method Validation means establishing by objective, evidence that the test method consistently produces a desired result required to satisfy the intended use.

What is the 21 CFR test method validation?

21 CFR 820.3 states: Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

What is the 21 CFR 820.3 definition of validation?

Definitions 21 CFR 820.3 (z)(1) Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

What is the test validation method?

Test validation is the process of verifying whether the specific requirements to test development stages are fulfilled or not, based on solid evidence. In particular, test validation is an ongoing process of developing an argument that a specific test, its score interpretation or use is valid.

What is the TMV process validation?

Test method validation is the process of demonstrating that a particular analytical method is suitable for its intended purpose and consistently produces reliable results.