Change Requests

Post-market complaint: HA-1000 display flicker

Complaint from Karolinska University Hospital: 2 HA-1000 units exhibit intermittent display flickering after 18 months of continuous operation. Suspected power supply capacitor aging.

Migrate cloud infrastructure to GDPR-compliant EU data center

Current US-based cloud hosting does not meet GDPR requirements for patient diagnostic data. Evaluate Azure West Europe and AWS eu-central-1 options.

Add Spanish and Portuguese language to IFU

Market expansion into LATAM region requires multilingual Instructions for Use. Translation validation required per SOP-DMS-001.

Transition to IVDR-compliant labeling

All IVD labels must comply with IVDR Annex I, Section 20 by May 2027. Project scope: 47 product labels, 12 IFUs, 3 outer packaging designs.

Upgrade HA-1000 firmware to v4.2

Firmware update includes: improved calibration algorithm, cybersecurity patches (IEC 81001-5-1), and data export format alignment with HL7 FHIR standards.

CAPA #IVD-2025-031: False positive rate deviation

Trend analysis detected 0.8% false positive rate increase in Lot 2026-R045. Root cause: antibody conjugation process temperature drift. Immediate containment: quarantine remaining lot inventory.

Reagent shelf life extension study

Accelerated stability data suggests potential 6-month shelf life extension for RGT-500 reagent cartridges. Requires real-time stability confirmation and IFU update.

IVDR Class C reclassification impact assessment

EU IVDR reclassification: RGT-500 test kits now classified as Class C (previously self-declared). Requires notified body involvement and updated technical documentation.