Reduced, digital Quality Management System (QMS) for 3D printing companies that want to supply semi-finished medical products (to hospitals or medical device companies) and/or work conform ISO 13485. 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.

Implementation follows the Quality BluePrint 5D Method

Other products

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