Quality Assurance

Our quality management system encompasses ISO 13485:2003 and ISO 9001:2008 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.

ISO9001:2008, ISO13485:2003, 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