Curriculum
Cover normal operation, patient selection, critical tasks, faults and conversion.
Deployment evaluation · 15
Training and proficiency
Define role-specific training, supervised practice, credentialing, ongoing exposure, assessment and loss-of-skill controls.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
15
FUURAA thesis
Completion of vendor training is a starting condition, not proof of independent clinical proficiency.
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.
Assessment
Use observable task and judgement criteria with failure thresholds.
Maintenance
Track case exposure, outcomes, refresher triggers and re-entry after absence.
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
Who defines independent-use readiness?
- 02
Are emergency skills assessed?
- 03
How is team proficiency measured?
- 04
What triggers supervision again?
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
Role-based curriculum and criteria
- 02
Evidence package 2
Observed assessment and outcome record
- 03
Evidence package 3
Credentialing and refresher decisions
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Case counts alone do not prove proficiency, and simulator performance does not replace supervised clinical assessment.
- 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.
U.S. FDA · Updated 2026-08-03
↗03Applying Human Factors and Usability Engineering to Medical Devices
Frames safe and effective use around intended users, uses, environments, interfaces, critical tasks and validation of use-related risk controls.
ISO · Published 2016-03 · confirmed 2025
↗ISO 13485:2016 — Medical-device quality management systems
Sets quality-system requirements for organisations involved in design, production, installation and servicing of medical devices.