Before you perform your Test Method Validation (TMV), you must perform an Installation Qualification (IQ) on the equipment. However, the extent of the qualification can vary and depends on the equipment itself. A simple caliper does not require the same equipment qualification as an HPLC.

Learn more about test method validation by reading our blog article:

https://www.sifo-medical.com/post/test-method-validation

You will learn what Test Method Validation is, why you should perform it, which types of TMV you should distinguish and sources of measurement errors.

To quickly validate your testing methods while complying with MedTech regulations and standards, follow our online TMV guides:

https://www.testmethodvalidation.com/r/EMl

Our TMV guides allow you to quickly validate your testing methods while complying with MedTech regulations and standards.

Receive a practical guide that shows you step-by-step how to validate your testing methods
Video tutorials
Pre-made templates
TMV Forum to ask specific questions
[Bonus] Checklists

We currently offer video tutorials and protocols for the validation of the following test methods:

Dye Penetration Test (according to ASTM F1929-23)
Seal Strength Test (according to ASTM F88/88M-23)
Bubble Test (according to ASTM F2096-11)
Visual Inspection (according to ASTM F1886-16)

Whether you are new to test method validation or want to refine your existing processes, this guide is an essential tool to ensure your test methods are accurate, reliable and compliant.
Lay the foundation for safe medical devices and validate your testing methods today!

Get your TMV guide: https://www.testmethodvalidation.com/r/EMl

PS: Don't forget to subscribe to our SIFo Medical YouTube channel to receive more valuable expertise on quality and supplier management in medical device manufacturing.

#medtech #medicaldevices #medizintechnik #regulatoryaffairs #medicaldevicemanufacturing #qualitycontrol #qualityassurance #medicaltechnology #testmethod #validation

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At SIFo Medical we are passionate about strengthening MedTech companies in the field of quality and supplier management. From our base in the Austrian Alps, we offer MedTech manufacturers our expertise in quality management, especially with:

– Compliant technical documentation
– Internal and external audits
– Test method validation
– Product development
– Process optimization
– Packaging validation
– Process validation
– Risk management
– Design check
– Statistics

On YouTube, our experts provide short, informative and easy-to-understand videos on medical device quality and supplier management to support MedTech manufacturers in producing safe medical devices and meeting the necessary regulations and standards (such as ISO 13485, MDR 2017/745 or FDA requirements).

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Website: www.sifo-medical.com
TMV guides: www.testmethodvalidation.com

Related topics:
Advice on medical devices
Quality management
Supplier management
Process validation
Operational qualification
Installation qualification
Performance qualification
Validation of test method
Validation of test method, step by step guide

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