Signal
Deduplicate events, code failure modes and preserve report uncertainty.
Deployment evaluation · 17
Post-market evidence
Combine complaints, incidents, recalls, corrections, maintenance, outcomes and exposure denominators without overstating passive reports.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
17
FUURAA thesis
Post-market signals are questions for structured investigation, not automatic verdicts.
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.
Exposure
Seek procedures, operating hours, configurations and population context.
Action
Track investigation, correction, communication and effectiveness checks.
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
Is a denominator available?
- 02
Are reports duplicates or incomplete?
- 03
Does the signal cluster by configuration?
- 04
Was corrective action effective?
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
Deduplicated signal dataset
- 02
Evidence package 2
Exposure and configuration estimates
- 03
Evidence package 3
Investigation and effectiveness record
Scope boundary
State what this evidence still cannot be generalised to.
- 01
MAUDE reports cannot calculate event rates, compare devices or establish causation by themselves.
- 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 · Database limitations verified 2026-08-15
↗02MAUDE adverse-event database and reporting limitations
Provides device reports that can reveal failure modes, complaint patterns and questions requiring further investigation.
ISO · Published 2019-12 · current edition verified 2026-08-15
↗03ISO 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
↗ISO 13485:2016 — Medical-device quality management systems
Sets quality-system requirements for organisations involved in design, production, installation and servicing of medical devices.