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Search FDA , found 8 results

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Medical Device FDA Guidance

fda-consultant-specialist

alirezarezvani/claude-skills

Provides FDA regulatory consulting for medical device makers, covering pathway selection (510[k]/PMA/De Novo), QSR compliance, HIPAA readiness, and device cybersecurity guidance for submissions.

Regulatory Affairs Leadership

regulatory-affairs-head

alirezarezvani/claude-skills

Provides senior regulatory strategy, submission management, pathway analysis, and global compliance coordination for HealthTech and MedTech organizations to speed market access.

Quality Non-Conformance

quality-nonconformance

sickn33/antigravity-awesome-skills

Guides experienced quality engineers through regulated manufacturing non-conformance control, from NCR lifecycle and disposition to RCA and CAPA, ensuring supplier quality and compliance in FDA, ISO, IATF, and AS9100 environments.

Clinical Report Writing

clinical-reports

K-Dense-AI/claude-scientific-skills

Draft case reports, diagnostic summaries, trial documents, and patient notes with templates and compliance checks for HIPAA, FDA, and ICH-GCP, including schematics generation via scientific-schematics to visualize timelines, algorithms, or CONSORT flows.

ClinPGx Database Access

clinpgx-database

K-Dense-AI/claude-scientific-skills

Provide REST API access to ClinPGx, the successor to PharmGKB, for querying gene-drug interactions, CPIC/DPWG/FDA guidelines, allele functions, and evidence that supports precision dosing and pharmacogenomics-driven clinical decisions.

FDA Regulatory Data Access

K-Dense-AI/claude-scientific-skills

Provides Python access to openFDA endpoints for drugs, devices, foods, veterinary products, and substances, enabling regulatory analysis, safety monitoring, recalls tracking, and pharmacovigilance research.

FDA Food Safety Auditor

fda-food-safety-auditor

sickn33/antigravity-awesome-skills

Transforms the assistant into an FDA food safety auditor that evaluates FSMA, HACCP, and preventive control records, highlights CCP gaps, and guides corrective actions before inspections.

MedTech Compliance Auditor

fda-medtech-compliance-auditor

sickn33/antigravity-awesome-skills

Turns your assistant into a MedTech Compliance Auditor that reviews SaMD and medical device files against 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and Part 11, surfacing findings with citations and remediation steps.

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