Our Certifications

Here you can downloads our certificates and instructions for use.

ISO 13485

Medical devices — Quality management systems

ISO 13485 specifies requirements for a quality management system where Surgimen needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 9001:2008

ISO 9001:2008 specifies requirements for a quality management system where Surgimen

  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and

  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

CE Mark

CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.

Certificate of Gurantee

We give a comprehensive guarantee for all the instruments we supply, provided that they were used as intended, conditioned and not altered. Normal wear due to use is not covered by this warranty. If a product should exhibit material defects despite our careful production and output control, it will be repaired or replaced free of charge after previous examination by our specialists.