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 current ISO 13485:2016 certificate is available for download here.