People
Define credentials, team roles, coverage, handoffs and escalation.
System anatomy · 08
Clinical operations and readiness
Engineer staffing, room setup, patient selection, supplies, cleaning, maintenance, escalation and fallback around the device.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
08
FUURAA thesis
Operational readiness determines whether verified device capability becomes dependable care.
Engineering map
Turn the title into engineering objects that can be observed, measured and reviewed.
Each layer states the boundary to establish and the evidence needed for the next decision.
Place
Verify layout, utilities, networks, sterility zones and emergency access.
Support
Plan consumables, preventive maintenance, service response and downtime.
Verification questions
Write the questions first, then decide whether a demo, test, pilot or operating record can answer them.
Each question needs an object, conditions, denominator, threshold and accountable decision owner.
- 01
What must be ready before the patient arrives?
- 02
Who can declare the system unavailable?
- 03
What is the safe backlog plan?
- 04
Are service dependencies tested?
Evidence to preserve
Enable the next reader to reconstruct conditions, results, failures and the decision.
A conclusion alone loses reviewability; raw records, configuration and exclusions matter too.
- 01
Evidence package 1
Site-readiness and daily-start checklist
- 02
Evidence package 2
Staffing, service and supply plan
- 03
Evidence package 3
Downtime and fallback drill
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Manufacturer installation does not by itself establish clinical readiness or resilient operations.
- 02
This is an engineering reading and decision framework; it does not replace application-specific risk assessment, conformity work, procurement acceptance or professional advice.
Sources and evidence status
Read standards scope, measurement evidence and application conclusions separately.
Source dates and review status remain visible; external sources open in a new tab.
01
U.S. FDA · Updated 2022-06-21 · verified 2026-08-15
↗02Computer-Assisted Surgical Systems
Explains authorised uses, clinician control, training, credentialing, facility responsibilities and adverse-event reporting for computer-assisted surgery.
ISO · Published 2016-03 · confirmed 2025
↗03ISO 13485:2016 — Medical-device quality management systems
Sets quality-system requirements for organisations involved in design, production, installation and servicing of medical devices.
Beijing Medical Products Administration · Published 2025-04-03
↗2025 inspection guide for surgical-robot manufacturing quality management
Details expectations spanning design, algorithms, assembly, software installation, inspection, supplier control, maintenance and after-sales capability.