Test Method Validation for Medical Device Manufacturers
Validate your test method now with SIFo Medical's practical step-by-step TMV guide - simple, practical and compliant.
MedTech-compliant.
Test Method Validation is mandatory in MedTech.
ISO 13485, ISO 11607 or MDSAP – our templates are compliant with all relevant
standards in the medical device industry (2025).
No prior knowledge necessary.
Are you new to test method validation? No problem.
We show you how to validate your test method step-by-step.
Save 100+ Hours.
No time or energy to work yourself through several guidelines and standards?
Save countless hours of work with the help of video instructions and ready-made templates.
Your Guide to Test Method Validation
As a medical device manufacturer, you must ensure that your packaging is safe and reliable to maintain the sterility of your products.
To meet regulatory requirements and guarantee patient safety, it is essential not only to perform test methods such as dye penetration tests, seal strength tests, bubble leak tests, or visual inspections but also to validate them thoroughly.
Our TMV guides provide you with practical video tutorials and ready-to-use templates to carry out these validations efficiently and in full compliance with the standards.
Your TMV-Guides
Validation of Dye Penetration Test acc. to ASTM F1929
The dye penetration test checks the integrity of sealed seams. This test is crucial to ensure that no microorganisms can penetrate sterile packaging. Our guide takes you step by step through the validation of this test method according to the ASTM F1929 standard, helping you achieve reliable and reproducible results.
Validation of Seal Strength Test acc. to ASTM F88/F88M
The seal strength test measures the strength of seals in medical packaging. This test is essential to ensure that the packaging remains intact during storage and transportation. Our guide shows you how to efficiently validate this test method, ensuring compliance with regulatory requirements.
Validation of Bubble Test acc. to ASTM F2096
The bubble leak test is used to check packaging for leaks by applying air pressure and inspecting for bubbles. This sensitive test detects even the smallest leaks that could compromise sterility. Our guide supports you in validating this test method, ensuring high product safety.
Validation of Visual Inspection acc. to ASTM F1886
The visual inspection assesses packaging for visible defects such as cracks, wrinkles, or incomplete seals. This test ensures that only flawless products leave the production line. Our guide provides a structured approach to validating this method, helping you minimize subjective evaluations.
Why You Should Validate Your Test Method:
Test Method Validation is required
by regulations
All important guidelines and standards in medical technology require the validation of your test methods, e.g. ISO 13485, ISO 11607, MDSAP
Test Method Validation increases the safety of your medical devices.
Validation ensures that your test method delivers reliable results - a TMV is the cornerstone for the manufacture of safe medical devices.
Your Practical Solution for Efficient Test Method Validation
Test Method Validation Made Easy – Benefit from the best practices of numerous successfully conducted validations in the medical device industry.
Video-Tutorials
Step-by-step instructions show you how to carry out your test method validation independently. The videos are designed to be feasible even without prior knowledge of medical technology.
Templates
Save yourself 100+ hours of work with ready-made templates that meet regulatory requirements.
Available Test Method Validation
We currently offer video tutorials and protocols for the validation of the following test methods:
- Dye Penetration Test (acc. to ASTM F1929-23)
- Seal Strength Test (acc. to ASTM F88/88M-23)
- Bubble Test (acc. to ASTM F2096-11)
- Visual Inspection (acc. to ASTM F1886-16)
About SIFo Medical
Your TMV-Expert Simon Foeger
For over 10 years, I have been supporting medical device manufacturers in quality management.
Here are the most important points at a glance:
- Consultant in MedTech
- ISO 13485 Lead Auditor
- I. and II. Party Process Auditor Medical Device
- External Trainer at TÜV SÜD for
- Process Validation
- Statistics in MedTech
- Test Method Validation
In recent years, I have noticed that there is a large knowledge gap on the subject of test method validation.
Some people are not even aware that they have to perform a TMV, and others struggle with the implementation — completely understandable because there are no concrete guidelines for performing a TMV.
That's why we've created practical video instructions and protocols to make it as easy as possible for you.
With the help of video instructions, I explain step-by-step what you need to do and how to fill in the ready-made templates.
This means the guide can be completed quickly without prior knowledge and complies with the most important medical technology regulations.
Implement a solid test method validation: safe & MedTech-compliant!
Validate Your Test Method Now
1 TMV-Guide
1360,- €
/ Guide- Standard Price for one TMV-Guide.
2 TMV-Guides
2176,- €
1088 € / Guide- 20 % discount on the purchase of 2 TMV-Guides.
3 TMV-Guides
2856,- €
952 € / Guide- 30 % discount on the purchase of 3 TMV-Guides.
4 TMV-Guides
3264,- €
816 € / Guide- 40 % discount on the purchase of 3 TMV-Guides.
Select your TMV-Guide
Click on the "Validate your test method" button, select your desired TMV guide and click on "Buy now".
Pay.
Create a user account and enter your details. You can then pay for the TMV guide directly online on our website. You will receive your invoice by e-mail.
Log in.
Log in with the access data you entered during the payment process.
Get started!
Follow the instructions in our TMV-Guide & lay the foundation for safe medical devices.
* If you require an invoice in advance, please send us an e-mail to: office@sifo-medical.com
Our References
Companies that trust us.
Q&A – frequently & not so frequently asked questions:
With our TMV Step-by-Step Guide, the estimated workload is around 8 hours, i.e. one working day. In addition, there is the sample preparation. Of course, the time required also depends largely on your internal processes (approval cycles, etc.).
The validation of test methods is a process in which we check whether a test method provides reliable results and is suitable for use in medical technology.
Correctly implementing a test method validation reduces the risk of faulty products on the market.
Test method validation is not just a requirement; it's crucial if you want to manufacture safe medical devices. The most important medical technology standards, such as ISO 11607, ISO 11608, or MDSAP, mandate the validation of your test method, underlining the gravity of this process.
For two main reasons:
1) Test Method Validation (TMV) is mandatory in the medical device industry.
All essential standards require a TMV (e.g., ISO 13485, ISO 11607, ...). In the MDR 2017/745 there is no direct requirement for a TMV, but indirectly (e.g.) through the reference in Article 10.9: "Manufacturers must have an appropriate quality management system (QMS)".
2) Validation of your test method massively increases the safety of your medical devices.
By validating your test method, you ensure its reliability. Regardless of who tests the devices, when, or where, you will reliably get the same result.
Certain standards must be followed when performing a test method, e.g., ASTM F1929 if you are performing a dye penetrant test or ASTM F88/F88M if you want to check the seal strength.
Yes, essential regulations and standards require test method validation. You should validate your test methods not only because standards require it but, above all, because it is a necessary process that contributes to the safety of your medical devices.
It is usually necessary to wade through countless directives and standards to understand which requirements you need to meet. When it comes to practical implementation, many questions and uncertainties arise.
You either get expensive external help or carry out the test method validation yourself, hoping this is sufficient.
However, a guessing game is never a good idea–especially regarding the safety of medical devices.
With our TMV Online Step-by-Step Guide, you get a concrete step-by-step guide that includes the necessary protocols to implement test method validation correctly and in compliance with the law in your company.
The guide is designed so you can carry out a TMV without prior knowledge. We provide the necessary knowledge and guide you through the process step-by-step.
You will receive all necessary templates and video tutorials to validate your test methods acc. to available standards.
We explain step-by-step, using video instructions, how to validate your test method and how to fill in the pre-made templates correctly.
What you'll get:
- Pre-Made Templates: Assessment Form, Protocol and TMV Report in Word-Format, Excel Sheet to organize your raw data
- Video-Instructions: we guide you through the process step-by-step. You will receive video tutorials on how to correctly fill in the pre-made templates and on how to analyze your data in Minitab.
- Access to TMV Online Forum, where you can ask questions or exchange ideas with other participants.
- Bonus: Checklists
The TMV step-by-step guide is designed so that you can carry out the test method validation without any prior knowledge of a working day (excluding time for sample preparation).
Optional:
On request (to office@sifo-medical.com) you can order a starter kit for carrying out the dye penetration test (ASTM F1929) from us. We will provide you with the necessary utensils:
- 50 μm tungsten wire
- Test ink according to DIN EN ISO 11607-1
- Injections
We at SIFo Medical have created the online guide on test method validation because numerous MedTech manufacturers have expressed a desire for a "common thread" or step-by-step instructions for carrying out test method validation.
MDR 2017/745, in particular, demands a lot from manufacturers. With this course, we offer you a quick-to-implement solution to validate your testing method following the law.
The TMV Step-by-Step Guide is suitable for quality managers and employees in quality management at medical device manufacturers.
Whether experienced in MedTech or new to test method validation, the TMV step-by-step guide is doable for everyone.
The TMV online guide is designed so you can carry out your test method validation in practice quickly and comply with all legal regulations.
This is not a theory course but rather a practical, step-by-step guide that you can follow without any prior knowledge.
If you are expecting a theory course, then this course is not suitable.
We currently offer the test method validation step-by-step guide for the following test methods:
- Dye Penetration Test according to ASTM F1929-23
- Seal Strength Test according to ASTM F88/F88M-23
- Bubble Test according to ASTM F2096-11
- Visual Inspection according to ASTM F1886/F1886M-16
You have two options to pay for the TMV guides:
1. Click on the "Validate Your Test Method" button, select the desired TMV guide, and add it to the cart. Then follow the instructions to complete the order. After payment, you will receive the invoice via email. Log in to our platform with your credentials to access the course content.
2. If you prefer to pay by bank transfer, please send an email to Sophia (office@sifo-medical.com) and let us know which TMV guides you would like to order. We will then send you the invoice via email. Once we receive the payment, you will receive the login details via email. office@sifo-medical.com
If you have any questions during the ordering process, please contact office@sifo-medical.com. office@sifo-medical.com.
The dye penetration test, according to ASTM F1929, is a standard test method for checking whether the seal seam of your packaging is tight.
To check this, you put a special test ink in the packaging and visually check whether the ink penetrates through the seal seam.
According to ASTM F1929, you can choose between three different methods of performing this test (injection method, edge dip method, or eyedropper method).
Further information about the standard can be found at: https://www.astm.org/f1929-15.html
According to ASTM F2096, bubble leak testing is a standard test method for detecting significant leaks in packaging.
It is a destructive test method that is suitable for tray and bag packaging.
Further information about the standard can be found at: https://www.astm.org/f2096-11r19.html
This standard test method checks the seal seam strength of the packaging.
This measures the force necessary to separate a test strip from the seal material. The test can be carried out on sealed seams between flexible and rigid materials.
Further information about the standard can be found at:
During the visual inspection, you check the sealing seams of your packaging. Pay particular attention to areas that have not been sealed properly, such as wrinkles, holes, or tears in the sealing seam.
Further information about the standard can be found at: https://www.astm.org/f1886_f1886m-16.html
You will find our general terms and conditions for digital content here: https://www.sifo-medical.com/general-terms-conditions-digital-content