Quality & Compliance

Documentation, supplier controls, safety, and regulatory expectations.

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