There’s an ongoing trend towards the personalisation of medical devices. Many of these custom-made or patient-matched implants are 3D printed. But how do you ensure the safety and efficacy of your 3D printed devices? How do you ensure consistent quality?
For this you need a Quality Management System (QMS)!
Qase3D can kickstart your ISO 13485 certification with the setup and implementation of an affordable fully digital Quality Management System. We have developed our unique Quality BluePrint 5D Method to help 3D printing companies and Point-of-Care facilities with the implementation of an easy-to-use QMS, based on ISO 13485, adapted to their specific processes.