GB Soluzioni overview:
- 10+ years experience on Machinery Directive and Process Validation.
- International reference with customers from Europe, South America, Middle East, China.
- Thousands of validations audited by FDA or ISO 13485 auditors.
- Thousands of CE marks applied to equipments, with documentation provided in more than 10 languages.
- Helping customers to obtain CE mark on medical devices from class I to III.
- No out of the box documentation or procedure, everything is compiled according to customer's business and quality system.
- State-of-the-art statistical methodologies to reach the correct data interpretation and to suggest the right corrective actions.
- Laboratory instrumentation with traceable calibration certificates.