Quality Assurance

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