A common question we often get is: Do we even have to validate a standard test method?
ISO 11607-2 gives the answer to this question – you must still demonstrate the test method's application in accordance with the standard, as well as its repeatability and reproducibility.
Do you have any further questions about Test Method Validation in the medical device industry?
🤓 For a more comprehensive summary of Test Method Validation in the MedTech industry, check out our blog posts at www.sifo-medical.com.
🚀 Validate your test methods quickly while being compliant with MedTech regulations and standards.
With our TMV-guides you will be able to validate your test methods quickly, while being compliant with MedTech regulations & standards.
✅ Get a practical guide that shows you how to validate your test methods, step-by-step
✅ Videos Tutorials
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Lay the foundation for safe medical devices & validate your test methods today!
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At SIFo Medical, we are passionate about empowering MedTech companies in Quality- and Supplier Management. From our base in the Austrian Alps, we provide MedTech manufacturers with our expertise in Quality Management, especially with:
- Compliant Technical Documentation
- Internal & External Audits
- Test Method Validation
- Product Development
- Process Optimization
- Packaging Validation
- Process Validation
- Risk Management
- Design Control
- Statistics
On YouTube, our experts provide short, informative, and easy-to-digest videos about medical device Quality- and Supplier Management to support MedTech manufacturers to produce safe medical devices and comply with necessary regulations and standards (like ISO 13485, MDR 2017/745 or FDA requirements).
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Related Topics:
Medical Device Consulting
Quality Management
Supplier Management
Process Validation
Operational Qualification
Installation Qualification
Performance Qualification
Test Method Validation
