ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, installation, and servicing of medical devices and related services. Published by the International Organization for Standardization (ISO), ISO 13485:2016 is specifically tailored to the medical device industry to ensure compliance with regulatory requirements and the delivery of safe and effective medical devices to patients. ISO 13485:2016 is widely recognized and adopted by organizations in the medical device industry worldwide, providing a framework for ensuring product quality, safety, and regulatory compliance.
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ISO certification is a globally acknowledged framework used to evaluate the management systems of companies on an international scale.
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