Quality

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

High quality standard at MELITEK

Production is conducted in line with GMP (EC 2023/2006) and our quality system is certified in accordance to ISO 9001:2008 to ensure superior product quality.

Our high quality standards include:

  • Use of medical quality raw materials
  • Production conducted under strict manufacturing procedures
  • Continuous in-process control processes
  • Rigorous quality testing before every product release
  • Certificate of analysis and technical delivery specification
  • Full lot traceability for 13 years
  • Retention of retain samples from each lot for min. 5 years
  • Change control procedures

Our quality policy is:

  • Quality on Time
  • Compliance to ISO9001:2008, customers’ and own requirements.
  • Continually implement quality improvements to maintain an efficient quality management system and reduce the quality costs.