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