ISO 13485 & MDR

Meeting the medical European standards

Fully validated process

Thanks to extensive knowledge of additive manufacturing and the surgical field, 3D Medical Models operates according to a fully validated process. All materials, software, and hardware used to produce patient-specific and surgical guides are ISO 13485 certified.

MDR 2020
The European Medical Device Regulations (MDR) impacts the entire medical device supply chain to monitor product safety and performance. One of the main objectives of these rules is to enhance patient safety and ensure that innovative medical devices remain available to patients. With a quality management system, 3D Medical Models offers reliability and quality in the delivered medical 3D-printed products.

ISO 13485 & MDR