We produce, test and deliver our meliflex products under rigorous quality inspection and in accordance with our customers' specific requirements.

Production is conducted in line with GMP (EC 2023/2006) and our quality system is certified in accordance to ISO 13485:2016 to ensure reliable product quality.

Our high quality standards include:

  • Use of high quality healthcare raw materials from leading producers
  • Production conducted under strict manufacturing procedures
  • Continuous in-process control processes
  • Rigorous quality testing before every product release
  • Certificate of Analysis for all lots supplied
  • Full lot traceability for 15 years
  • Retention of retain samples from each lot for min. 5 years
  • Change control managment procedures

Our quality policy is:

  • Quality on Time
  • Compliance to ISO 13485:2016, customers’ and own requirements
  • Continually implement quality improvements to maintain an efficient quality management system and reduce the quality costs

The ISO 13485:2016 certificate valid from 2021-2024 is available for download here.