The MDR Management System is designed for hospitals, 3D labs and medical device manufacturers that produce custom-made medical devices.
These organisations must adhere to the European Medical Device Regulation (MDR). Our system makes compliance practical and straightforward; covering all essential QMS elements required by law, without the complexity of a full ISO 13485 system.

The MDR Management System focuses on the (minimum) regulatory requirements of the MDR — practical, lean, and tailored for Point-of-Care 3D printing. The ISO 13485 quality system is a comprehensive QMS for medical device manufacturers, covering all the requirements of this quality standard.

Yes, with the MDR Management System you can. The system includes ready-to-use documentation, templates and clear guidance to work independently in full MDR compliance. Qase3D will support with its setup, training and yearly audits.
For the ISO 13485 quality system, a responsible Quality Manager is strongly advised.

3D printing or Additive Manufacturing allows for complex and organic designs, mimicking, matching and/or mirroring human anatomy. Furthermore, it allows the production of porous structures, enabling osseointegration. 3D printing facilitates mass customization; custom-made (or patient-matched) devices for every patient. But also standard medical devices can be 3D printed (with a lattice structure), for example spinal cages and acetabular cups.

Providing it is done right, definitely yes. But, same as with other manufacturing technologies (like CNC milling) you need good control of the whole workflow, not only the process of 3D printing, but also the design, raw material, post-processing, cleaning, sterilisation. That's were a Quality Management System comes in.