ISO 13485 is a quality system standard specifically geared to medical device manufacturers the latest version was published in 2016 (ISO 13485:2016). Whether you are new to 13485 or not, it is vital to use a QMS solution that enables easy adherence to quality system regulations. Those manufacturers who have yet to address ISO 13485 should start assessing their quality management system (QMS) to determine whether there are any gaps to meet the ISO 13485 guidelines. United States medical device manufacturers that already address ISO 13485 will have a leg up to address FDA regulations. The announcement that the FDA plans to use ISO 13485 as the basis for its quality system legislation signals an important step forward for the international standard, which is already widely used globally.

Without a unified approach to both, the daily practice of ensuring that regulatory processes are followed and properly documented is even more challenging. Environmental & Export Controls ComplianceĪs globalization of medical device supply chains has continued to increase, regulatory bodies have grappled with how to bridge the gap between domestic and foreign regulation.

Iso 13485 fda