TMV Guide
Validate the Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F1886/F1886M-16 Visual Inspection
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 F1886/F1886M-16 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_Visual_Inspection_ASTM_F1886_F1886M_16.docx
54.38 KB
Word
30 min.
Validation Protocol
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Get a ready-to-use Attribute Agreement Analysis protocol in an editable Word format, designed for fast adaptation to your specific test method. In the video, Simon walks you through each section, showing exactly how to complete it in line with MedTech regulatory requirements.
Downloads:
Protocol_TMV_Visual_Inspection_ASTM_F1886_16_Template.docx
108.78 KB
Word
30 min.
Raw Data Analysis
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Easily organize and analyze your raw data. Use the Excel template and step-by-step video guide to structure your test data clearly and efficiently, saving time, reducing errors, and laying the groundwork for a solid TMV report.
Downloads:
TMV_RawData_attribute_3O_2T_15P_5G_10B.xlsx
27.07 KB
Excel
30 min.
Minitab Analysis
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Master your analysis in Minitab.
This video walks you through the entire data analysis process in Minitab, making it easy to interpret your results and complete your TMV with confidence.
30 min.
TMV Report
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Document your Attribute Agreement Analysis with clarity and confidence. This Test Method Validation (TMV) Report Template helps you clearly document the effectiveness of pass/fail results from visual inspection methods used to assess seal integrity in flexible medical packaging. Designed for regulatory compliance, the template ensures your analysis is both structured and audit-ready.
Downloads:
Report_TMV_Visual_Inspection_ASTM_F1886_16_Template.docx
64.69 KB
Word
30 min.
Please note: This guide offers validation instructions and templates. It does not include the full text of the applicable 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 visual inspection of sterile packaging, 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.
