1,360.00 €
1360.0 EUR 1,360.00 €
1,360.00 €
Responsible Sophia Hurmann
Last Update 12/07/2024
Completion Time 2 hours 26 minutes
Members 5
Start here: TMV Step-by-Step Guide
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ASTM F2096-11: TMV Bubble Test
TMV Step-by-Step Guide

Start here: Before you start validating test methods (TMV), please read through our written guide. Here we summarize the theory you need to know about TMV in a nutshell. The following content awaits you: 

- Basics: Test Methods 

- Basics: Test Method Validation

- Regulatory & Normative Requirements 

- How to prepare for your TMV. 

- Checklist: Compliant Test Method Validation

TMV Protocol: Bubble Test acc. to ASTM F2096-11
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ASTM F2096-11: TMV Bubble Test
Template | Protocol: TMV acc. to ASTM F2096-11

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TMV Assessment Form: Bubble Test acc. to ASTM F2096-11
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ASTM F2096-11: TMV Bubble Test
Template | Assessment Form: TMV acc. to ASTM F2096-11

Please download the document to edit it.

Raw Data Analysis: How to Organize Raw Data in Excel
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ASTM F2096-11: TMV Bubble Test
Excel Sheet | Raw Data Analysis

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TMV Report: Bubble Test acc. to ASTM F2096-11
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ASTM F2096-11: TMV Bubble Test
Template | TMV Report: Bubble Test acc. to ASTM F2096-11

Please download the document to edit it.

BONUS
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ASTM F2096-11: TMV Bubble Test
Checklist: Is Your Test Method Validation Compliant?

Use this checklist to ensure your test method validation complies with all relevant MedTech regulations and standards.

ASTM F2096-11: TMV Bubble Test
Checklist: How to Prove Your Test Method Intended Purpose

Use a decision tree to prove the intended purpose of your test method.

ASTM F2096-11: TMV Bubble Test
Checklist: Test Method Validation (Step-by-Step)

Use this checklist to ensure that you do not forget any important steps when validating your test methods.