TMV Guide
Validate the Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F88/F88M-23 Seal Strength Test
Training contents
3 hrs. 0 min.
TMV Guide: The Basics
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Our guide walks you through the fundamentals of Test Method Validation (TMV) in the medical device industry. It covers the key regulatory and normative requirements, outlines how to prepare effectively for a TMV, and includes a practical checklist to support compliance.
The written guide includes:
- Basics: Test Methods
- Basics: Test Method Validation (TMV)
- Regulatory and Normative Requirements
- How to prepare for your TMV
- Checklist: Compliant Test Method Validation
Downloads:
TMV_Guide_20250820.pdf
1.44 MB
PDF
30 min.
Assessment Form
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Use this Work Instruction Assessment Form as documented proof that ASTM F88/F88M-23 is fully integrated into your quality management system. In the video, Simon guides you through the Assessment Form template, explaining all relevant details.
Downloads:
Assessment_Form_TMV_Seal_Strength_Test_ASTM_F88_F88M_23_Template.docx
594.03 KB
Word
30 min.
Validation Protocol
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The test method validation protocol assesses the effectiveness of pass/fail results generated by the standard test method for seal strength of flexible barrier materials. The video guide provides step-by-step instructions, with Simon walking you through the protocol template in detail.
Downloads:
Protocol_TMV_Seal_Strength_ASTM_F88_23_Template.docx
80.91 KB
Word
30 min.
Raw Data Analysis
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Use the Excel template and accompanying video to organize your raw data efficiently and clearly.
Downloads:
TMV_RawData_variable_3O_2T_10P.xlsx
9.84 KB
Excel
30 min.
Minitab Analysis
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This video demonstrates how to analyze your data in Minitab. You will be guided through the analysis step-by-step.
30 min.
TMV Report
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Use this Test Method Validation (TMV) Report Template to clearly document the effectiveness of pass/fail results from the seal strength test for flexible barrier materials (per ASTM F88). With the included step-by-step video guide, you’ll learn how to complete each section, saving time and avoiding common validation pitfalls.
Downloads:
Report_TMV_Seal_Strength_ASTM_F88_Template.docx
61.83 KB
Word
30 min.
Please note: This guide provides practical instructions and templates for test method validation. It does not include the full text of the ASTM standard.
Who is this guide suitable for?
This TMV Guide is ideal for MedTech professionals – including QA/RA Managers, Validation Engineers, Quality Engineers, Process Engineers, and Supplier Quality Engineers – who need to validate test methods, such as the seal strength test, to ensure reliability and meet regulatory requirements and industry standards.
Special Pricing for Multiple Guides
Receive discounts when purchasing multiple guides in a single order: 20% off for 2 guides, 30% off for 3 guides, and 40% off for 4 guides.
