Configuration
Bind hardware, firmware, software, models, instruments and consumables.
System anatomy · 07
Device and software assurance
Treat mechanics, software, algorithms, sensors, instruments, networks and accessories as one controlled safety case.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
07
FUURAA thesis
The clinically deployed configuration—not an isolated component—is the unit that must remain verified.
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.
Verification
Cover nominal, boundary, fault, timing, interference and recovery behaviour.
Release
Require traceability, approval, installation check and rollback readiness.
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 configuration was tested?
- 02
Which interfaces are safety-critical?
- 03
How are model and software changes controlled?
- 04
Can the previous safe state be restored?
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
Configuration bill and trace matrix
- 02
Evidence package 2
Verification, anomaly and release records
- 03
Evidence package 3
Installation and rollback evidence
Scope boundary
State what this evidence still cannot be generalised to.
- 01
A component certificate or bench result does not validate the integrated clinical configuration.
- 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
ISO · Published 2019-12 · current edition verified 2026-08-15
↗02ISO 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
↗03ISO 13485:2016 — Medical-device quality management systems
Sets quality-system requirements for organisations involved in design, production, installation and servicing of medical devices.
U.S. FDA · Final guidance 2025-06-27 · page verified 2026-08-15
↗04Cybersecurity in Medical Devices
Addresses secure design, labeling, premarket documentation, vulnerability management and patient-safety preparation across the product lifecycle.
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.