Quality Management
for MedTech Companies
Update your Quality Management System to achieve excellence.
Regulatory requirements are tightening, and MDR 2017/745 demands more than ever.
Many medical device manufacturers struggle with documentation gaps, unclear expectations, and limited resources – especially with the notified body bottleneck adding pressure. Instead of scrambling at the last minute, get ahead with expert support.
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At SIFo Medical, we specialize in:
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Design Control – Structuring product development for compliance
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Test Method Validation – Ensuring accurate and compliant testing
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Process Validation – Demonstrating robust, repeatable manufacturing
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Packaging Validation – Meeting regulatory and integrity requirements
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Risk Management – Proactive strategies aligned with ISO 14971
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​We customize our services to fit your specific needs.
Let’s connect and explore how SIFo can support your projects.
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