Spentys MDR and ISO Certifications

To provide our software and services to healthcare providers, Spentys complies with strict quality and regulatory standards. Over the past years, we have undergone several audits and implemented a comprehensive Quality Management System (QMS) to ensure our processes and products meet the highest requirements for safety and quality.

Our Quality Management System

Spentys has an internal Quality Management System (QMS) aligned with ISO 13485 requirements, allthough it is not formally ISO 13485 certified. This internationally recognized standard governs the design, production, and distribution of patient-specific orthopedic devices. Our QMS is structured around ten core processes, covering everything from management, design, and production to logistics, quality assurance, and regulatory affairs.

By following this framework, we ensure:

Compliance with statutory and regulatory requirements.
Continuous improvement of our processes.
Safe, effective, and high-quality products for patients.

MDR Compliance

Spentys is registered as a Class I custom-made medical device manufacturer under the European Medical Device Regulation (MDR 2017/745).

While the custom-made 3D printed devices we produce fall under MDR, the Spentys software itself is not considered a medical device.

The software is covered under our End User License Agreement (EULA). The software is a tool that enables user to create custom made 3D (design) products.

FDA Compliance (United States)

In addition to our European MDR and ISO certifications, Spentys ensures that its products also comply with applicable U.S. FDA requirements.

Custom-made medical devices: Spentys’ 3D-printed orthopedic devices are provided as custom-made, patient-specific Class I medical devices, which are exempt from the FDA’s Premarket Notification [510(k)] process.
Quality standards: Our devices are produced under our Quality Management System, which aligns with the FDA’s Quality System Regulation (21 CFR Part 820).
Documentation: As with the MDR framework in Europe, Spentys provides appropriate documentation for each device manufactured, demonstrating compliance with both U.S. and international quality and safety standards.
Software: The Spentys software itself is not classified as a medical device under the FDA. It falls under our End User License Agreement (EULA).

This ensures that healthcare providers in the U.S. can confidently use Spentys devices and software in accordance with FDA regulations.

Documentation Provided

Whenever Spentys produces custom-made medical devices, we supply a Declaration of Conformity with each product. This certifies that the device was manufactured in compliance with MDR requirements and our QMS.

Overview of Certifications and Documentation

Notification to the AFMPS (Federal Agency for Medicines and Health Products in Belgium).
Audit by the AFMPS, confirming no non-conformities were identified.
Declaration of Conformity, provided with all 3D-printed devices produced by Spentys.
For the software: the EULA.

More Information

If you would like further details about our certifications or our quality management system, please contact your Spentys representative or reach out to us at info@spentys.com.