The requirements for Test Method Validation (TMV) are difficult to determine. There are no explicit requirements in MDR 2017/745. ISO 13485:2016 mentions Test Method Validation in 7.5.6 or 7.6. among others. The US FDA does have a clear requirement under 21 CFR 820.72.
ISO 11607-1 states that all Test Method Validations shall be validated.
Our recommendation is to read the MDSAP Audit Approach:
MDSAP AUDIT APPROACH:
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If you want to get useful support when validating your test methods, check out our TMV-guides:
📌 [ Ссылка ]
With video tutorials and templates you will be able to validate your test methods quickly, and compliant with MedTech regulations and standards.
Lay the foundation for safe medical devices and validate your test method today! 💪
PS: Don't forget to subscribe to our SIFo Medical YouTube channel to receive more valuable expertise about 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 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
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- Product Development
- Process Optimization
- Packaging Validation
- Process Validation
- Risk Management
- Design Control
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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
