A Fortune 500 Class III implantable device manufacturer needed to verify their AIMDs were safe for patients undergoing MRI scans. The challenge: characterize RF-induced heating, electromagnetic interference, and device functionality under simulated MRI conditions, with full FDA V&V.
Good Automation designed and built an automated RF test set for MRI compatibility characterization, a five-axis robotic arm for spatial mapping of inductive charging fields, and a custom RF injection system for MRI field simulation. Later modernized the test software platform for improved throughput. All work performed under 21 CFR 820.70(i).