Matthew Jorgensen

Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

Thor Rollins, Martell Winters, and Matthew Jorgensen, PhD collaborated on a whitepaper that is available for download: Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

This whitepaper is an in-depth look at the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices. 3D-printed orthopedic medical devices are gaining attention and popularity due to their potential for enhanced biocompatibility, customizability, and cost-effectiveness. As of late 2015, FDA had cleared more than 85 total 3D-printed medical devices, with more regulatory clearances on the horizon.

The whitepaper is available for download on the Qmed website or click HERE.

Quick Guide to FDA’s Draft Guidance on 3D Printed Devices

Posted in Printing Services by MDDI Staff on May 24, 2016

By: Matthew R. Jorgensen, PhD

A new leapfrog guidance from FDA gives a glimpse into the agency’s thinking on 3D printed medical devices.

On May 10, 2016, FDA released a leapfrog guidance document on the technical considerations for additive manufactured or 3D printed devices. Leapfrog guidance documents provide valuable information on what is in the regulatory pipeline and allow interested parties to have a voice in the development of FDA guidance.

Continue reading on the MDDI website for key points from the draft guidance pertaining to the testing of medical devices.