Installation & IQ/OQ/PQ
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls for robotic, monitoring, and laboratory platforms.
Service you can run an OR on
99.5% uptime SLA planning across Intuitive Surgical installed assets. Mean-time-to-repair targets under 6 working hours for Tier-1 hospitals when contracted.
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls for robotic, monitoring, and laboratory platforms.
OEM-recommended PM schedule with documented 21 CFR Part 11 traceability and NIST-linked calibration where applicable.
24/7 dispatch · Tier 1-3 escalation · OEM parts inventory across Intuitive Surgical regional hubs.
Lifecycle handoff
Power, HVAC, RF shielding, network, and boom clearance verified against IEC 60601-1-2 EMC.
Installation, operational, and performance qualification documented against the design history file (DHF) and device master record (DMR) before first clinical case.
Console, bedside, and biomed competency records with superuser pathways and good manufacturing practice (GMP) change-control awareness for field updates.
Scheduled PM, cybersecurity patch deployment, mean time between failures (MTBF) and mean time to repair (MTTR) tracking, and release-to-use evidence.
Unique device identification (UDI) deregistration, IT asset wipe (NIST SP 800-88), post-market surveillance (PMS) closeout, recycling certificate.
Schedule a service audit
Include facility type, asset count, operating hours, market, and the evidence your quality team must retain. Response targets are contractual, not universal clinical uptime promises.