Topic

quality-systems

Quality-system controls for service organizations.

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

A generic medical monitor with interchangeable modules and a blank service dossier on a clinical-engineering workbench

Quality & ComplianceAug 26, 20269 min read

How to Qualify a Medical Equipment Service Provider: An Evidence Checklist

A risk-tiered framework for clinical engineering leaders to audit and qualify independent service organizations (ISOs), fulfilling CMS Conditions of Participation, Joint Commission EC.02.04.01, and ISO 13485 supplier controls.

By Ran Chen

An unbranded service evidence case containing test leads, calibration blocks, a reference module, and a blank dossier

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