zod-4
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zustand-5
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scope-rule-architect-angular
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stream-deck
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gentleman-bubbletea
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gentleman-e2e
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gentleman-installer
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gentleman-system
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jira-task
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dotnet
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jira-epic
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ai-sdk-5
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homebrew-release
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go-testing
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django-drf
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judgment-day
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nextjs-15
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playwright
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pr-review
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pytest
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react-19
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sdd-apply
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sdd-archive
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sdd-design
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sdd-explore
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sdd-init
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sdd-propose
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sdd-spec
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sdd-tasks
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sdd-verify
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skill-creator
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skill-registry
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quality-documentation-manager
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.
quality-manager-qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
quality-manager-qms-iso13485
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support.
regulatory-affairs-head
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Provides regulatory strategy development, submission management, pathway analysis, global compliance coordination, and cross-functional team leadership.
risk-management-specialist
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
senior-computer-vision
Computer vision engineering skill for object detection, image segmentation, and visual AI systems. Covers CNN and Vision Transformer architectures, YOLO/Faster R-CNN/DETR detection, Mask R-CNN/SAM segmentation, and production deployment with ONNX/TensorRT. Includes PyTorch, torchvision, Ultralytics, Detectron2, and MMDetection frameworks. Use when building detection pipelines, training custom models, optimizing inference, or deploying vision systems.
qms-audit-expert
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.
mdr-745-specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.
isms-audit-expert
Information Security Management System auditing for ISO 27001 compliance, security control assessment, and certification support
information-security-manager-iso27001
ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use for ISMS design, security risk assessment, control implementation, ISO 27001 certification, security audits, incident response, and compliance verification. Covers ISO 27001, ISO 27002, healthcare security, and medical device cybersecurity.
gdpr-dsgvo-expert
GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.
fda-consultant-specialist
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
capa-officer
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
ux-researcher-designer
UX research and design toolkit for Senior UX Designer/Researcher including data-driven persona generation, journey mapping, usability testing frameworks, and research synthesis. Use for user research, persona creation, journey mapping, and design validation.
ui-design-system
UI design system toolkit for Senior UI Designer including design token generation, component documentation, responsive design calculations, and developer handoff tools. Use for creating design systems, maintaining visual consistency, and facilitating design-dev collaboration.
product-strategist
Strategic product leadership toolkit for Head of Product including OKR cascade generation, market analysis, vision setting, and team scaling. Use for strategic planning, goal alignment, competitive analysis, and organizational design.
product-manager-toolkit
Comprehensive toolkit for product managers including RICE prioritization, customer interview analysis, PRD templates, discovery frameworks, and go-to-market strategies. Use for feature prioritization, user research synthesis, requirement documentation, and product strategy development.
agile-product-owner
Agile product ownership for backlog management and sprint execution. Covers user story writing, acceptance criteria, sprint planning, and velocity tracking. Use for writing user stories, creating acceptance criteria, planning sprints, estimating story points, breaking down epics, or prioritizing backlog.
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