mdr

QasE3D & Waveland Create Easy QMS Platform For MDR-Compliant Medical Devices

Erik Boelen and his firm, QasE3D, are quality management consultants to the 3D printing industry. He partnered with Waveland European Lawyers to create a simple tool to help companies stay…

3MF Becomes ISO Standard

The 3MF file format has become an ISO Standard, becoming part of ISO/IEC 25422:2025. The file format is still open source, and it is hoped that this move will build…

What Medical Device Regulation Might Mean for 3D Printed Patient-Specific Implants

You would be hard pressed to find a sane member of society who would advocate for a removal of all oversight in the field of medicine. However, that doesn’t mean…