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TECHNICAL CONSULTING SERVICES

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• PASSIVATION, CLEANING, AND DISINFECTION (ISO 19227 & ASTM F3127, ISO 17664)

• PACKAGING DESIGN, PROCESS VALIDATION AND SHELF-LIFE (ISO 11607)

• PRODUCT MARKING AND LABELING (ISO 20417, ISO 28219, ISO 15223 & ASTM F2943)

• STERILIZATION (ISO 14937, ISO 11135, ISO 11137, ISO 17665)

• REPROCESSING OF SINGLE-USE DEVICES AND REUSABLE INSTRUMENTS

• SYSTEMATIC RISK MANAGEMENT (ISO 14971)

• REGULATORY FILINGS (FDA 510(k) / PMA / NDA and EU Technical File & Design Dossier)

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