This is the most recent version of the ISO 13485 standard, which was created using a process-oriented approach to eliminate operational mistakes and risks in the management system. ISO 13485:2016 is compatible with other ISO management system standards because it is proposed with a high-level framework and PDCA cycle. Furthermore, its risk-based thinking approach enables firms to constantly meet the needs of their consumers. https://ias-certification.com/ca/iso-13485-certification-in-canada/