Fda Consultant Specialist
alirezarezvani/claude-skills/ra-qm-team/skills/fda-consultant-specialistby alirezarezvani19392f7a0826No license27K starsListed Oct 8, 2026Updated Oct 8, 2026Repository updated 5 weeks ago
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
Only the file list is public. File contents are available once the skill is installed in a workspace.
| Path | Size | Type |
|---|---|---|
| references/device_cybersecurity_guidance.md | 17.9 KB | text/markdown |
| references/fda_capa_requirements.md | 21.9 KB | text/markdown |
| references/fda_submission_guide.md | 11.5 KB | text/markdown |
| references/hipaa_compliance_framework.md | 18.8 KB | text/markdown |
| references/qsr_compliance_requirements.md | 21.3 KB | text/markdown |
| scripts/fda_submission_tracker.py | 19.2 KB | text/plain |
| scripts/hipaa_risk_assessment.py | 22.6 KB | text/plain |
| scripts/qsr_compliance_checker.py | 26.6 KB | text/plain |
| SKILL.md | 11.8 KB | text/markdown |
Source and attribution
Source:alirezarezvani/claude-skillsinra-qm-team/skills/fda-consultant-specialistat commit19392f7
License: No license
Content belongs to its original authors. SourceWeft indexes it from a public repository.
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