Together with the Waveland team of European Lawyers, QasE3D has developed a Management System that guarantees MDR compliance for custom-made devices at Point-of-Care.
⚠️More information will be added here soon!
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The MDR Management System focuses on the (minimum) regulatory requirements of the MDR; practical, lean, and tailored for custom-made medical devices. The ISO 13485 Light quality system is a reduced QMS for Point-of-Care facilities, covering the core requirements of this quality standard, yet not the MDR requirements. So if you want to be MDR compliant, you need the MDR Management System. If you are looking to get ISO13485 certified at some point, you (also) need the ISO 13485 (Light) QMS.