Risk file
Trace hazards, controls, residual risk and benefit-risk conclusions.
Reading method · 04
Govern benefit-risk over the lifecycle
Connect premarket hazards and controls to training, maintenance, complaints, updates, corrective action and retirement.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
04
FUURAA thesis
Medical-robot safety is a maintained evidence system, not a one-time launch gate.
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.
Signals
Define complaint, incident, cybersecurity and performance triggers.
Action
Predefine investigation, field correction, retraining, restriction and retirement.
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
Which controls need post-market confirmation?
- 02
What triggers reassessment?
- 03
Who can restrict use?
- 04
How are changes linked to field evidence?
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
Versioned risk-management file
- 02
Evidence package 2
Signal thresholds and review minutes
- 03
Evidence package 3
Corrective-action and closure evidence
Scope boundary
State what this evidence still cannot be generalised to.
- 01
A quality-system certificate or historic authorisation does not prove current configuration performance.
- 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
ISO · Published 2019-12 · current edition verified 2026-08-15
↗02ISO 14971:2019 — Medical-device risk management
Specifies a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk and monitoring control effectiveness.
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.
U.S. FDA · Database limitations verified 2026-08-15
↗04MAUDE adverse-event database and reporting limitations
Provides device reports that can reveal failure modes, complaint patterns and questions requiring further investigation.
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.