SIFo Medical – Your Partner for Quality and Compliance in MedTech

Medical device manufacturers need fast, reliable quality management – without drowning in paperwork or audit surprises.

That's exactly where SIFo Medical delivers.

Founded by Simon Foeger, a certified TÜV SÜD trainer with 15+ years in MedTech QA/RA, SIFo Medical combines deep regulatory expertise with practical, AI-powered tools – built for teams who need compliant results, not just theory.

What SIFo Medical offers:

QUALITY MANAGEMENT
Process Validation · Test Method Validation · Packaging Validation · Design Control · Risk Management 

SUPPLIER MANAGEMENT
Supplier Development · Supplier Audits · Sourcing MedTech-compliant components (global supplier network, including Asia)

AI-POWERED TOOLS
SIFo AIRA – AI-driven ISO 14971 risk analysis. Cut risk documentation time from 400+ hours to under 5. Audit-ready, structured, and built specifically for medical device manufacturers.
https://sifo-medical.com/en/aira-ai-risk-analysis

TRAINING & DIGITAL RESOURCES
Test Method Validation Online Training: https://sifo-medical.com/en/online-trainings/test-method-validation-training
Practical TMV Guides: https://sifo-medical.com/en/online-trainings/tmv-guides
TMV Online Training: https://sifo-medical.com/en/online-trainings/test-method-validation-training
Free templates, checklists & resources: https://sifo-medical.com/en/free-resources

Who SIFo Medical works with:
MedTech disposable manufacturers · Medical device startups · QA/RA teams under audit pressure · Companies navigating ISO 13485, ISO 14971, EU MDR, or FDA 21 CFR Part 820

📩 office@sifo-medical.com
🌐 www.sifo-medical.com
▶️ YouTube (free tutorials): www.youtube.com/@SIFoMedical
📬 Newsletter: http://eepurl.com/ifoepD

SIFo Medical

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