Topic

medical-device-repair

Medical equipment repair and service operations.

Quality & ComplianceAug 26, 20269 min read

Medical Device Servicing vs Remanufacturing: How to Draw and Document the Boundary

An operational guide to the FDA May 2024 final guidance on medical device remanufacturing, detailing the 6 guiding principles, the two-phase decision tree, and documentation frameworks for HTM and ISO teams.

By Ran Chen

Repair OperationsAug 26, 20269 min read

MRI Coil Repair vs Replacement: An Evidence-Based Service Decision Framework

A clinical engineering decision framework for evaluating MRI surface and phased-array coil failures, navigating component repair versus replacement economics, and validating RF safety and SNR performance under NEMA and IEC standards.

By Ran Chen