ISO 13485 Medical Devices – Quality Management System Standard audits are conducted in two stages in accordance with the certification process of our national and international representations.
Organizations can benefit from the commercial advantages of an internationally recognized quality certificate,.Establishing the necessary infrastructure to put the CE mark on the products,.Raising awareness of employees about hygiene and sanitation,.Minimizing the problems that may be encountered in the audits of organizations that have the legal right to audit,.Reducing of waste / scrap amount and returns in production,.Meeting the demands of consumers regarding medical device safety,.In organizations applying ISO 13485 Medical Devices – Quality Management System Thanks to some basic features of ISO 13485, such as risk management and record control, it integrates the requirements into management systems that will enable organizations to easily defend themselves in compensation lawsuits. In the process of compliance with the European Union, all medical device manufacturers aim to establish and certify a quality system to meet current legal obligations, meet customer expectations, increase their efficiency and create a legal assurance. ISO 13485 Standard quality system certification is a step for medical device manufacturers to use the CE mark on their products.
