Services
ISO 13485:2016 service procedures · IEC 60601-1 preventive maintenance intervals · NIST-traceable calibration on every visit for Icare monitoring, dental, and laboratory fleets.
Coverage matrix
| Service Tier | Coverage | On-site Response | Documentation |
|---|---|---|---|
| Platinum 24/7 | 365d × 24h, all fault classes | ≤ 4h urban / ≤ 8h rural | IQ/OQ/PQ + 21 CFR Part 11 audit trail |
| Gold | Mon–Sun 07:00–19:00 | ≤ 8h | OQ/PQ + signed service report |
| Silver | Mon–Fri 08:00–17:00 | NBD parts shipping | PM compliance log |
| Per-Call | On-demand | 24–72h | Service report only |
Methodology
Service interface to your QMS is defined per clause 7.5.1 Production & Service Provision, including PM intervals for SpO2 modules, dental autoclaves, and chemistry analyzers. Quality system regulation (QSR) and good manufacturing practice (GMP) supplier attestations are available on request.
Icare qualifies OEM and third-party service partners with audited design history file (DHF) / device master record (DMR) access, CAPA visibility for field-replaceable units, and risk-benefit analysis for accepted deviations.
Cybersecurity patches, firmware updates, and SaMD defect fixes are risk-classed, versioned, and released with SBOM deltas. Unique device identification (UDI) is logged on every FRU swap.
Service Assessment Plan, FRACAS trending, mean time between failures (MTBF) / mean time to repair (MTTR) dashboards, clinical evaluation report (CER) excerpts where applicable, and adverse event reporting (MDR) extracts for your post-market surveillance (PMS) file. 510(k) substantial equivalence summaries are product-specific; premarket approval (PMA) devices — if any — are labeled separately and never described as “FDA approved” when only 510(k) cleared.
Service boundaries
Platinum 24/7 response assumes urban FSE coverage denser than one engineer per 120 connected endpoints; rural sites default to Gold or Silver with parts staging. Remote commissioning (roadmap 2028) still requires local power, network, and LIS / EMR credentials. Calibration certificates are NIST-traceable for listed modules only; SpO2 accuracy re-verification after sensor-family changes needs a new OQ. Icare will not describe 510(k) cleared devices as “FDA approved.”
24-page PDF covering PM calendars, calibration certificates, and Part 11 audit-trail examples for connected monitors and IVD platforms.
Download (PDF, 24 pages)