Quality Management Systems (QMS) for medical devices are cumbersome as layers upon layers of critical checks ensure the safety and effectiveness required for the consumer. However, in an effort to reduce overly burdensome recordkeeping processes FDA has announced a voluntary QMS switch from 21 CFR 820 to ISO 13485:2016. CFR 820 is and will remain the law, but this move to ISO 13485:2016 would harmonize the FDA Quality Systems and supplant the existing requirements with the specifications of an international consensus standard for medical device manufactures. ISO uses an improved risk management and risk-based decision-making approach in all processes of the quality management system. FDA expects to fully transition to standard ISO 13485:2016 for medical devices sometime in 2019.
It’s important for medical device firms to get this QMS transition right. EAS offers expertise and assistance in moving from CFR 820 to ISO 13485, facilitating a smooth transition and ensuring compliance. If you missed our recent webinar on the new QMS system, we invite you to view it on-demand here. For more information on our services or to discuss your regulatory challenges please contact Bryan Coleman, Senior Director for Pharmaceuticals and Medical Devices.