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Quality Management

Kantech Medical System is proud to have always surpassed the legal requirements to ensure that each instrument reaching surgeon’s hands is a testament to surgical craftsmanship.

ISO 9001:2015

Kantech Medical System has implemented quality management system, which has been certified to ISO 9001:2015. This certification ensures that the company constantly delivers products that meet all customers’ needs and regulatory requirements and requires that we commit to the improvement of the system and ongoing conformity to regulations.

ISO 13485:2016

We are proud to have achieved recognition as a company certified to the ISO 13485 medical device manufacturing standard.

The highlights of ISO 13485 requirements are:

– Promotion and awareness of regulatory requirements as a management responsibility.
– Controls in the work environment to ensure product safety.
– Focus on risk management activities and design control activities during product development.
– Specific requirements for inspection and traceability for medical devices.
– Specific requirements for documentation and validation of processes for medical devices.
– Specific requirements for verification of the effectiveness of corrective and preventive actions.

PMS (Post Marketing Surveillance) activities consist of a process in which the performance and safety of medical devices are continuously monitored after the supply of products to the market. The necessity for post-market monitoring of a medical device begins immediately after the medical device is placed on the market.





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