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 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.