Identify
Version every safety- and performance-relevant component and dependency.
Scope boundary · 20
Configuration and change control
Reassess software, models, instruments, accessories, consumables, networks, site workflow and maintenance changes before clinical use.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
20
FUURAA thesis
Evidence belongs to a configuration and use system; uncontrolled change breaks that link.
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.
Assess
Determine regulatory, risk, verification, usability, training and clinical impact.
Release
Approve, install, confirm, monitor and retain rollback evidence.
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 changed since supporting evidence?
- 02
Does the change alter intended use or risk?
- 03
Which evidence must be repeated?
- 04
Can affected cases be traced?
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 configuration baseline
- 02
Evidence package 2
Change-impact and approval record
- 03
Evidence package 3
Deployment, monitoring and rollback log
Scope boundary
State what this evidence still cannot be generalised to.
- 01
A vendor update notice or successful installation does not establish continued clinical acceptability.
- 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 · Final guidance 2025-06-27 · page verified 2026-08-15
↗02Cybersecurity in Medical Devices
Addresses secure design, labeling, premarket documentation, vulnerability management and patient-safety preparation across the product lifecycle.
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
↗04ISO 13485:2016 — Medical-device quality management systems
Sets quality-system requirements for organisations involved in design, production, installation and servicing of medical devices.
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.