ISO 13485:2016 is the most recent version of the ISO 13485 standard, which was developed with a process-oriented approach in mind to reduce operational errors and hazards in the management system. Because it is presented with a high-level framework and PDCA cycle, ISO 13485:2016 is compatible with other ISO management system standards. Furthermore, its risk-based thinking style helps businesses to satisfy the demands of their customers on a continuous basis.

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