II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--risk-management-iso14971
risk-management-iso14971 overview
Medical Device Risk Management per ISO 14971 - Conduct comprehensive risk management throughout the medical device lifecycle including hazard identification, risk estimation, risk evaluation, risk control, and residual risk assessment.
Attributes
displayName
risk-management-iso14971
description
Medical Device Risk Management per ISO 14971 - Conduct comprehensive risk management
throughout the medical device lifecycle including hazard identification, risk estimation, risk evaluation,
risk control, and residual risk assessment.
libraryPath
library/specializations/domains/science/biomedical-engineering/risk-management-iso14971.js
specialization
biomedical-engineering
references
- - ISO 14971:2019 Medical devices - Application of risk management to medical devices - ISO/TR 24971:2020 Guidance on the application of ISO 14971 - FDA Guidance on Risk Management: https://www.fda.gov/regulatory-information/search-fda-guidance-documents
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/risk-management-iso14971', {
deviceName: 'Cardiac Pacemaker',
intendedUse: 'Cardiac rhythm management for bradycardia patients',
deviceCategory: 'Active Implantable',
existingRiskData: null
});
usesAgents
- general-purpose
Outgoing edges
lib_applies_to_domain1
- domain:biomedical-engineering·DomainBiomedical Engineering
lib_belongs_to_specialization1
- specialization:biomedical-engineering·SpecializationBiomedical Engineering
lib_implements_workflow2
- workflow:experiment-design·WorkflowExperiment Design
- workflow:peer-review-cycle·WorkflowPeer Review Cycle
lib_involves_role2
- role:biomedical-engineer·RoleBiomedical Engineer
- role:research-engineer·RoleResearch Engineer
lib_requires_skill_area3
- skill-area:data-analysis·SkillAreaData Analysis
- skill-area:sensor-fusion·SkillAreaSensor Fusion
- skill-area:statistical-analysis·SkillAreaStatistical Analysis
Incoming edges
None.