Topic: ai-automation
2,090 skills in this topic.
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clinical-study-designer
Clinical study design skill for medical device trials including IDE studies and post-market studies
a5c-ai/babysitter 514
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cybersecurity-risk-assessor
Medical device cybersecurity risk assessment skill per FDA premarket and postmarket guidance
a5c-ai/babysitter 514
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design-fmea-generator
Design Failure Mode and Effects Analysis (DFMEA) skill for systematic design risk identification
a5c-ai/babysitter 514
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design-review-facilitator
Design review planning and execution skill for structured design phase gate reviews per 21 CFR 820.30
a5c-ai/babysitter 514
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dicom-conformance-validator
DICOM conformance testing and integration skill for medical imaging systems
a5c-ai/babysitter 514
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eu-mdr-gspr-mapper
EU MDR General Safety and Performance Requirements (GSPR) mapping and compliance documentation skill
a5c-ai/babysitter 514
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extractables-leachables-analyzer
E&L study design and data analysis skill for chemical characterization of medical devices
a5c-ai/babysitter 514
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fatigue-life-predictor
Fatigue life prediction skill for implants and load-bearing devices using validated approaches
a5c-ai/babysitter 514
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fda-510k-submission-generator
Automated 510(k) premarket notification preparation for generating submission packages, predicate device comparisons, and substantial equivalence arguments
a5c-ai/babysitter 514
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fea-mesh-generator
Finite element mesh generation skill optimized for biomedical geometries including implants, anatomical structures, and tissue models
a5c-ai/babysitter 514
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iec62304-lifecycle-manager
Medical device software lifecycle management skill implementing IEC 62304 requirements
a5c-ai/babysitter 514
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image-algorithm-validator
Medical image processing algorithm validation skill for segmentation, detection, and analysis algorithms
a5c-ai/babysitter 514
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iso-standards-compliance-checker
Medical device standards compliance verification skill for ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards
a5c-ai/babysitter 514
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iso10993-evaluator
Biological evaluation planning skill implementing ISO 10993-1 for biocompatibility testing strategy
a5c-ai/babysitter 514
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iso14971-risk-analyzer
Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis
a5c-ai/babysitter 514
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material-model-library
Biomaterial constitutive model library skill providing validated material properties for biological tissues and implant materials
a5c-ai/babysitter 514
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motion-capture-analyzer
Motion capture data processing and analysis skill for gait analysis and biomechanical studies
a5c-ai/babysitter 514
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opensim-modeler
OpenSim musculoskeletal modeling skill for biomechanical simulation and analysis
a5c-ai/babysitter 514
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packaging-validation-planner
Sterile barrier system validation planning skill per ISO 11607
a5c-ai/babysitter 514
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process-fmea-generator
Process Failure Mode and Effects Analysis (PFMEA) skill for manufacturing risk assessment
a5c-ai/babysitter 514
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prosthetics-design-optimizer
Prosthetics and orthotics design optimization skill integrating biomechanical requirements with manufacturing constraints
a5c-ai/babysitter 514
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requirements-traceability-manager
Design control traceability skill for managing user needs, design inputs, design outputs, and verification/validation linkages
a5c-ai/babysitter 514
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scaffold-design-optimizer
Tissue engineering scaffold design optimization skill for pore size, porosity, and mechanical properties
a5c-ai/babysitter 514
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software-vv-test-generator
Medical device software verification and validation test case generation skill
a5c-ai/babysitter 514