Medical devices must be manufactured in accordance with a compliant quality management system. The system’s documentation should meet the defined requirements of this standard.

The manufacturer should have an efficient quality management system that is capable of meeting all their responsibilities under the Quality System Regulations (QSR) and other applicable regulations.

Manufacturers should have a management representative who is responsible for the quality system and be fully aware of the regulatory requirements and has the authority to ensure these are fulfilled. He/she should also determine how compliance with ISO 13485:2016 will be achieved, monitored, audited, maintained, and improved through documented procedures.

The manufacturer must have a documented procedure for the product to meet ISO 13485:2016 requirements. iso 13485 certificate