In the ever-changing and highly regulated medical device manufacturing field, guaranteeing product quality and patient safety is not just about a legal obligation—but also a strategic imperative. Effective complaint management and vigilance systems, as per ISO 13485:2016, form the backbone of any robust Quality Management System (QMS). These mechanisms ensure compliance with global re... https://www.freyrsolutions.com/blog/complaint-management-and-vigilance-in-medical-devices-a-strategic-approach-aligned-with-iso-134852016