Achieve full MDR compliance for medical 3D printing in hospitals
Hospitals that produce custom-made medical devices (using 3D printing) fall under the European Medical Device Regulation (MDR).
This regulation is complex and especially in the field of 3D printing, its practical meaning is often unclear.
That’s why we, together with Waveland, offer a dedicated MDR Management System (€990/year) designed specifically for custom-made devices at the Point-of-Care. This QMS is much easier and smaller than ISO13485.
Developed by European Lawyers
The system has been developed by European Lawyers who have thoroughly analysed and interpreted the MDR, translating it into a clear, practical framework.
This means you can work confidently and compliantly, without having to interpret the regulation yourself.
Where the MDR is often seen as vague, this system makes compliance practical, structured, and verifiable.
Always up to date
Because the system is online, it is continuously maintained and automatically updated in line with the latest MDR requirements.
You’re always working according to the most current version of the regulation and our yearly audits keep you compliant; ready for any inspection or external audit.
Why choose this system?
✅ Tailored for 3D labs producing custom-made devices
✅ Affordable
✅ Peace-of-mind about MDR compliance
✅ Practical, clear and easy to implement
✅ Much smaller and easier than ISO13485
✅ Automatically updated, so always compliant
✅ Audits & implementation support by Qase3D
✅ Includes ready-to-use templates, checklists and workflows for 3D printing
A partnership between Waveland and Qase3D
This MDR Management System combines Waveland lawyers in-depth MDR-know-how with Qase3D’s expertise in quality management and audits for medical 3D printing.
Together, we deliver a complete, practical and lean solution for hospitals that 3D print custom-made medical devices.
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