Stage
Name model, oversight, jurisdiction and enrolment status.
Scope boundary · 19
Research is not clinical treatment
Label simulation, bench, animal, cadaver, first-in-human, feasibility and authorised clinical use as different stages.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
19
FUURAA thesis
Promising research can justify the next study without justifying routine patient access.
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.
Question
State whether the work tests feasibility, safety, performance or clinical benefit.
Access
Separate trial participation, compassionate access and marketed use.
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
Were humans treated under a study?
- 02
Was the device authorised for that use?
- 03
Are results complete or selected?
- 04
What study must happen next?
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
Study registration and protocol
- 02
Evidence package 2
Ethics and regulatory status
- 03
Evidence package 3
Complete results and next-evidence plan
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Innovation-task selection, prototype demonstration and research publication are not product registration or clinical availability.
- 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
China NMPA · Published 2025-07-03
↗02Lifecycle regulation measures supporting high-end medical devices
Calls for classification guidance for surgical and rehabilitation robots, naming consensus, standards work and lifecycle regulatory support.
European Commission MDCG · MDCG 2020-1 · March 2020
↗03Clinical 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
↗ISO 14971:2019 — Medical-device risk management
Specifies a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk and monitoring control effectiveness.