BIRMINGHAM, Ala.--(BUSINESS WIRE)--The coming mandate for Unique Device Identification (UDI) Systems for medical devices has left some providers wondering if they’re truly ready. The answer, if ...
Following the lifecycle approach of the MDR, the identification system aims to enhance the effectiveness of the post-market safety-related activities. The system brings about two key obligations: ...
PITTSBURGH--(BUSINESS WIRE)--Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced the release of an innovative and automated ...
A few short months from now, manufacturers of Class III medical devices must comply with FDA’s unique device identification (UDI) rule. Part 1 of this series focused on the need for companies to start ...