Standards and Guidelines Test Method Validation in the medical device industry:
Automotive Industry Action Group Measurement System Analysis Reference Manual
ASTM F3263 (specifically for the medical device industry):
[ Ссылка ]
Further links:
AIAG MSA-4:2010:
[ Ссылка ]
Deutsche Akkreditierungsstelle – DAkkS 71SD4019:2015-01-14:
[ Ссылка ]
The Fitness for Purpose of Analytical Methods:
[ Ссылка ]
For a more comprehensive summary of Test Method Validation in the MedTech industry, check out our blog posts at www.sifo-medical.com.
🚀 If you want to validate your test methods quickly while being compliant with MedTech regulations and standards, follow our online TMV guides:
👉 [ Ссылка ]
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
✅ Premade 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 (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)
Whether you're new to test method validation or looking to refine your existing processes, this guide is an essential resource for ensuring your test methods are accurate, reliable, and compliant.
Lay the foundation for safe medical devices & validate your test methods today!
📌 Get your TMV guide at: [ Ссылка ]
PS: If you enjoy our content, please like and subscribe to our channel to receive updates about new #MedTech videos.
#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
- 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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Subscribe to SIFo Medical today and never miss out on valuable MedTech expertise.
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LinkedIn SIFo Medical: [ Ссылка ]
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Website: www.sifo-medical.com
Related Topics:
Medical Device Consulting
Quality Management
Supplier Management
Process Validation
Operational Qualification
Installation Qualification
Performance Qualification
Test Method Validation
