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Engineered for hospital teams. Audited under ISO 13485 and IEC 60601-1.

Hospital care team reviewing connected device fleet
Patient Monitoring, IVD, and Rehabilitation Programs

Smith And Nephew products for clinically accountable device procurement

Bring remote care workflows, laboratory readiness, and post-acute rehabilitation equipment into one service-backed device program with documented interoperability, UDI traceability, and procurement-ready evidence packs.

99.5%target uptime SLA
24/7field service triage
UDIprocurement traceability
FHIRremote care integration
4,800+devices supported across acute and post-acute care
61qualified procurement and clinical search terms mapped
3priority product categories for this site
14 daytarget documentation response for value analysis teams
Regulatory packets

Evidence and compliance files built for hospital review

Each procurement track is packaged for clinical engineering, materials management, privacy, and value analysis committees that need specifics before standardization.

ISO

ISO 13485:2016

Quality-system documentation, supplier controls, complaint handling flow, CAPA escalation, and design-change traceability.

IEC

IEC 60601-1

Electrical safety, operator competency, preventive maintenance intervals, and biomedical acceptance checklist.

UDI

UDI / GUDID Ready

Device identifiers, lot capture, recall workflow, barcode scanning, and ERP upload formats for purchasing teams.

FHIR

HL7 FHIR R4

Observation mapping, remote monitoring payloads, interface ownership, and cybersecurity review materials.

Care settings

Coverage across the workflows your committee compares

ICU

Connected Monitoring

Alarm policy alignment, waveform review, telehealth handoff, and FHIR observations for remote care programs.

LAB

IVD & Laboratory

CLIA complexity, LIS connectivity, QC documentation, reagent traceability, and TAT expectations for central labs.

REH

Rehabilitation

Hospital-to-home bundles, caregiver training, durable equipment lifecycle, and payer documentation support.

GPO

Value Analysis

Lifecycle cost modeling, trade-in options, service tiers, documentation packets, and committee-ready comparison tables.

"
Smith And Nephew helps our committee move from product interest to operational readiness: service coverage, training records, interface notes, and reimbursement documentation arrive in a format our teams can actually review.

Value Analysis Director, regional health system

QMS21 CFR 820

Supplier-control review files and complaint handling SOPs prepared for audit teams.

SLA4h urban

Escalation targets for field service, loaner equipment, and critical replacement parts.

PMS90 day

Post-market surveillance review cadence for complaints, corrections, and preventive actions.

BAAHIPAA

Privacy workflow for connected devices, remote monitoring data, and vendor access boundaries.

Build a procurement packet around your care setting.

Send the device class, facility type, installed-base size, and timeline. A clinical specialist will return a structured quote path with service, documentation, and training options.