Technical
Measure accuracy, latency, force, reliability and software behaviour.
Reading method · 03
Separate evidence layers
Keep engineering verification, usability, clinical performance, regulatory status and operational outcomes distinct.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
03
FUURAA thesis
Evidence travels only as far as its design, population, comparator and jurisdiction permit.
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.
Clinical
Measure patient-important benefit and harm against relevant care.
Regulatory
Record jurisdiction, pathway, authorised wording and conditions.
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 exact question did the study answer?
- 02
Was the comparator clinically relevant?
- 03
Is the evidence independent and reproducible?
- 04
Which claim remains unsupported?
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
Claim-to-evidence matrix
- 02
Evidence package 2
Study protocol and complete results
- 03
Evidence package 3
Regulatory decision and labeling
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Bench, animal, cadaver, simulation and early-feasibility results must retain their original evidence status.
- 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
European Commission MDCG · MDCG 2020-1 · March 2020
↗02Clinical evaluation and performance evaluation of medical device software
Connects valid clinical association, technical performance and clinical performance to a documented evaluation under the applicable regulation.
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.
China NMPA · Published 2025-07-03
↗Lifecycle regulation measures supporting high-end medical devices
Calls for classification guidance for surgical and rehabilitation robots, naming consensus, standards work and lifecycle regulatory support.