Installation & IQ/OQ/PQ
Validated commissioning for related kit hardware and storage systems under 21 CFR 820 and ISO 13485:2016 design controls, with UDI enrollment into hospital materials systems.
Service & Support
99.5% program fill-rate goal across Sunrise Medical infection-control accounts. Mean-time-to-repair under 6 working hours for Tier-1 hospital kit equipment when covered by an active service agreement.
Validated commissioning for related kit hardware and storage systems under 21 CFR 820 and ISO 13485:2016 design controls, with UDI enrollment into hospital materials systems.
OEM-recommended PM schedule for dispensers, wipe stations, and sterile-barrier sealers with documented 21 CFR Part 11-ready service records.
24/7 dispatch · Tier 1–3 escalation · OEM parts inventory across Sunrise Medical regional hubs for program accounts.
Power, HVAC, storage humidity, and shielding notes for SPD and unit supply rooms.
Validated commissioning with acceptance checklists and UDI master-data load.
Superuser training covering AAMI ST91 handling notes and IFU contact-time rules.
PM per 21 CFR 820 / OEM schedule with FRACAS closure notes.
IT asset de-identification where applicable, UDI deregistration, and recycling certificate.
Tell us facility type, asset or dispenser count, and whether you need Premier / Vizient / HealthTrust contract notes. We return a service pathway with MTTR targets and documentation owners.