Record
Capture authority, pathway, decision date, identifier and holder.
Deployment evaluation · 13
Authorised intended use
Verify the current primary regulatory record before relying on a product page, hospital announcement or research paper.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
13
FUURAA thesis
Regulatory status is jurisdiction-, configuration- and claim-specific.
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.
Scope
Extract indication, population, operator, environment and contraindications.
Configuration
Match model, software, accessories, instruments and labeling revision.
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 the record current and primary?
- 02
Does the marketed name match the authorised model?
- 03
Is use off-label or investigational?
- 04
What conditions attach to use?
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
Regulatory record snapshot
- 02
Evidence package 2
Label-to-claim comparison
- 03
Evidence package 3
Configuration and jurisdiction matrix
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Approval, clearance, registration and conformity assessment are not interchangeable terms.
- 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.
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.
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.