Our ISO 13485 Certification and the QMS implemented allows us to make a commitment to customers and regulators.


Process improvement and validation, monitoring and control activities since the incoming of raw materials until the finished product release, control of deviations and changes, internal and external audits, qualification of suppliers are some of the activities performed by our company to ensure the compliance with regulatory requirements thereby providing a high level of customer protection, health and safety of patients and users, thus ensuring the satisfaction and confidence of our clients.


The company owns a KGMP certificate since 2016 assigned by the Korean authorities.