II.
LibrarySkill overview
Reference · livelib-skill:biomedical-engineering--adverse-event-reporter
adverse-event-reporter overview
Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance
Attributes
displayName
adverse-event-reporter
description
Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance
libraryPath
library/specializations/domains/science/biomedical-engineering/skills/adverse-event-reporter/SKILL.md
specialization
biomedical-engineering
contentSummary
# Adverse Event Reporter Skill
## Purpose
The Adverse Event Reporter Skill supports adverse event monitoring and regulatory reporting for medical devices, ensuring compliance with FDA MDR requirements and EU vigilance obligations.
## Capabilities
- MDR reportability assessment
- FDA For
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:compliance-engineer·RoleCompliance Engineer
lib_requires_skill_area3
- skill-area:statistical-analysis·SkillAreaStatistical Analysis
- skill-area:data-analysis·SkillAreaData Analysis
- skill-area:compliance-automation·SkillAreaCompliance Automation
Incoming edges
None.