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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 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.