II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--post-market-surveillance
post-market-surveillance overview
Post-Market Surveillance System Implementation - Implement post-market surveillance systems to monitor device safety and performance in the field per FDA and EU MDR requirements.
Attributes
displayName
post-market-surveillance
description
Post-Market Surveillance System Implementation - Implement post-market surveillance systems
to monitor device safety and performance in the field per FDA and EU MDR requirements.
libraryPath
library/specializations/domains/science/biomedical-engineering/post-market-surveillance.js
specialization
biomedical-engineering
references
- - EU MDR Article 83-86 Post-Market Surveillance - FDA 21 CFR 803 Medical Device Reporting - MDCG 2020-7 PMCF Plan Template
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/post-market-surveillance', {
deviceName: 'Implantable Cardioverter Defibrillator',
deviceClass: 'Class III',
markets: ['US', 'EU', 'Japan'],
riskProfile: { riskClass: 'high', implantable: true }
});
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.