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ISO 13485 Certification for Medical Device
ISO 13485 is an international standard for the design, manufacture and distribution of medical devices. ISO 13485:2016 is the latest version by ISO. This standard is based on the ISO 9001:2015 process model approach.

ISO 13485 is a process-based approach which defines, implement, and improve effectiveness of a quality management system that they expected by customers and regulatory requirements. The main aim of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems.