ISO 13485 Medical devices

Medical devices, which can be hardware or even software used in the treatment of patients or in the diagnosis of various diseases, have a significant effect on patient safety and risk management in the medical field. The ISO 13485-based quality management system helps medical device manufacturers reduce the risk of developing devices that could cause problems for patients. It is an international standard for the certification of medical devices, used in the construction of a management system.

It was created for medical device manufacturers and suppliers and is based on ISO 9001. The responsibility to proactively contribute to the fight against bribery. The implementation of the standard helps the organization to design reasonable and proportionate measures to prevent, detect and combat bribery.