Qualification & Validation
Qualification et validation
Process validation:
- FOT (first of tool)
- SAT (Site Acceptance test)
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
Product validation:
- Functional product validation
- Shelf life validation
- Transport validation
- Biocompatibility testing (subcontracted)
Regulatory Affairs:
- Regulatory monitoring
- Support for technical documentation and CE registration
- Support for FDA registration
End-to-end support: Qualification & Validation
Our products are developed and manufactured in compliance with international Health standards (ISO 13485, ISO 15378, FDA 21 CFR part 820).
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