II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--clinical-evaluation-report
clinical-evaluation-report overview
Clinical Evaluation Report Development - Develop clinical evaluation reports demonstrating clinical safety and performance of medical devices per MEDDEV 2.7/1 and EU MDR requirements.
Attributes
displayName
clinical-evaluation-report
description
Clinical Evaluation Report Development - Develop clinical evaluation reports demonstrating
clinical safety and performance of medical devices per MEDDEV 2.7/1 and EU MDR requirements.
libraryPath
library/specializations/domains/science/biomedical-engineering/clinical-evaluation-report.js
specialization
biomedical-engineering
references
- - MEDDEV 2.7/1 Rev 4 Clinical Evaluation - EU MDR 2017/745 Article 61 Clinical Evaluation - MDCG 2020-13 Clinical Evaluation Assessment Report Template
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/clinical-evaluation-report', {
deviceName: 'Coronary Drug-Eluting Stent',
riskClass: 'Class III',
intendedPurpose: 'Treatment of coronary artery stenosis',
equivalentDevices: [{ name: 'Predicate DES', manufacturer: 'Example Corp' }]
});
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.