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.