Our quality management system encompasses ISO 13485:2016 and supports everything we do for our customers. Quality laboratories, fully equipped with the latest technical innovations, provide comprehensive support to the process management systems ensuring consistent product quality.
- ISO13485:2016, FDA compliant
- FMEA/Risk Analysis/Risk Benefit Analysis
- Advanced product quality planning (APQP)
- Production Planning Approval Process (PPAP)
- Regulatory Affairs Management
- Support in the preparation of Design & Drug Master Files
- Metrology Laboratories incorporating optical and contact CMMs
- Bespoke test equipment
- Bioburden monitoring of product and production environment
- Validation and qualification