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Quality Assurance
Project Management
Risk Assessment
Quality Assurance

- Development and implementation of Full Quality Assurance System (FQAS) according to MDD or ISO13485

- FDA 510(k) applications for e.g. syringes, implants, surgical devices etc.

- Auditing (internal/supplier)

- Sterilisation processes (Gamma, EtO, Steam)

- Biocompatibility evaluation and testing (ISO10993-1)

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