3D Innovation Lab at Humanitas University has officially achieved ISO 13485 certification, becoming the first university in Italy authorized to design and manufacture custom-made 3D‑printed medical devices.

This milestone positions the Lab as a certified medical device producer, ensuring full compliance with international quality, safety, and regulatory standards.

A Certified Hub for Advanced 3D Medical Manufacturing
ISO 13485 is the globally recognized standard for quality management systems in the medical device industry.
With this certification, 3D Innovation Lab can now deliver patient‑specific, clinically validated, and regulation‑compliant 3D‑printed devices, supporting surgeons, hospitals, and research centers with high‑precision anatomical models and custom surgical tools.

The certification confirms the Lab’s ability to manage the entire production workflow — from imaging‑based design to additive manufacturing and quality control — under strict regulatory oversight.

Supporting Personalized Medicine and Surgical Innovation
The Lab’s certified production capabilities enable:
- Custom-made anatomical models for surgical planning and training
- Patient‑specific phantoms for simulation and education
- Tailored surgical guides and tools developed in collaboration with clinicians
- Regulatory‑compliant R&D pathways for new medical device concepts

This achievement strengthens Humanitas University’s role as a leader in medical innovation, bridging academic research with industry‑grade manufacturing.

A First in Italy’s Academic Landscape
Humanitas University is now the first Italian university to obtain ISO 13485 certification for custom-made 3D‑printed medical devices — a recognition that underscores its commitment to excellence, safety, and technological advancement.

The announcement highlights the strategic importance of the Lab:

“Humanitas University becomes the first university certified for the production of custom-made medical devices,”
as stated in the official communication.

Driving the Future of 3D‑Printed Healthcare
With ISO 13485 certification, 3D Innovation Lab expands its mission to support clinicians with reliable, high‑fidelity, and regulation‑compliant 3D solutions, accelerating the adoption of personalized medicine and next‑generation surgical technologies.