II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--eu-mdr-technical-documentation
eu-mdr-technical-documentation overview
EU MDR Technical Documentation - Develop technical documentation meeting EU Medical Device Regulation (MDR) 2017/745 requirements for CE marking including GSPR mapping and clinical evaluation.
Attributes
displayName
eu-mdr-technical-documentation
description
EU MDR Technical Documentation - Develop technical documentation meeting EU Medical Device
Regulation (MDR) 2017/745 requirements for CE marking including GSPR mapping and clinical evaluation.
libraryPath
library/specializations/domains/science/biomedical-engineering/eu-mdr-technical-documentation.js
specialization
biomedical-engineering
references
- - EU MDR 2017/745 Annex II Technical Documentation - EU MDR 2017/745 Annex I General Safety and Performance Requirements - MDCG Guidance Documents
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/eu-mdr-technical-documentation', {
deviceName: 'Diagnostic Ultrasound System',
riskClass: 'IIa',
intendedPurpose: 'Non-invasive diagnostic imaging',
notifiedBody: 'BSI'
});
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.