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Legal, Clinical & Regulatory

Your EU Medical Device Regulation Guide

Big changes are underway for the European market and how it regulates medical devices with the recent unveiling of the Medical Device Regulation MDR 2017/745.

CAPA Notes from an FDA Inspection

Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by John Gagliardi while participating in the interactions between the inspector and the medical device manufacturer.

The Fused and the Fractured: New Entrants to U.S. Spine and Trauma

Globus Medical has received clearance for its first two trauma products. While they prepare to enter that space, numerous competitors are bringing out interbody fusion devices for introduction in U.S.