{"schemaVersion":1,"siteId":"meddevicerepair","locale":"en","generatedAt":"2026-08-27T06:27:48.060Z","count":3,"items":[{"id":"meddevicerepair:en:medical-device-servicing-vs-remanufacturing","sourceId":"medical-device-servicing-vs-remanufacturing","type":"article","title":"Medical Device Servicing vs Remanufacturing: How to Draw and Document the Boundary","summary":"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.","url":"https://meddevicerepair.com/blog/medical-device-servicing-vs-remanufacturing","imageUrl":"https://meddevicerepair.com/content/medical-device-servicing-vs-remanufacturing.webp","publishedAt":"2026-08-26T00:00:00.000Z","updatedAt":"2026-08-26T00:00:00.000Z","locale":"en","tags":["medical-device-repair","quality-systems","service-documentation"],"author":"Ran Chen","category":"Quality & Compliance","newsletterEligible":true,"priority":60,"contentHash":"b908390c6e4a3a33f549509ad57897b87de75baed687c55bf55a187a94d07353"},{"id":"meddevicerepair:en:medical-equipment-service-provider-qualification","sourceId":"medical-equipment-service-provider-qualification","type":"article","title":"How to Qualify a Medical Equipment Service Provider: An Evidence Checklist","summary":"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.","url":"https://meddevicerepair.com/blog/medical-equipment-service-provider-qualification","imageUrl":"https://meddevicerepair.com/content/medical-equipment-service-provider-qualification.webp","publishedAt":"2026-08-26T00:00:00.000Z","updatedAt":"2026-08-26T00:00:00.000Z","locale":"en","tags":["quality-systems","service-documentation"],"author":"Ran Chen","category":"Quality & Compliance","newsletterEligible":true,"priority":60,"contentHash":"47f3f269f4bdfe9d16fa3ee7a3699767912767e50269c03ed7fdbdad152b634f"},{"id":"meddevicerepair:en:mri-coil-repair-vs-replacement","sourceId":"mri-coil-repair-vs-replacement","type":"article","title":"MRI Coil Repair vs Replacement: An Evidence-Based Service Decision Framework","summary":"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.","url":"https://meddevicerepair.com/blog/mri-coil-repair-vs-replacement","imageUrl":"https://meddevicerepair.com/content/mri-coil-repair-vs-replacement.webp","publishedAt":"2026-08-26T00:00:00.000Z","updatedAt":"2026-08-26T00:00:00.000Z","locale":"en","tags":["medical-device-repair","quality-systems"],"author":"Ran Chen","category":"Repair Operations","newsletterEligible":true,"priority":60,"contentHash":"d47f9d1035ef994734fe9865230d6f18589d235f190baef2bdf5a0061f9f713b"}]}