Reduced, digital Quality Management System (QMS) for Point-of-Care 3D Labs that want to work conform ISO 13485 because they want to spin-out or supply to other hospitals in the future . This QMS does not cover all the requirements of the standard, so it cannot be certified as-is, but it can be extended later to a full, certifiable QMS. This QMS does not cover MDR requirements (for this, look at the MDR Management System below).

Implementation follows the Quality BluePrint 5D Method

Other products

ISO 13485 for Medical Device companies
ISO 13485 Light for 3D printing companies
MDR Management System for Point-of-Care 3D Labs