FDA Consultant Specialist
技能 已验证 活跃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.
To provide expert, actionable guidance on navigating complex FDA regulations for medical device companies, ensuring compliance and successful submissions.
功能
- FDA pathway guidance (510(k), PMA, De Novo)
- QSR (21 CFR 820) compliance assessment
- HIPAA compliance framework for medical devices
- Device cybersecurity requirements
- Submission tracking and readiness checks
- Supporting Python tools for analysis
使用场景
- Use when planning an FDA submission for a new medical device.
- Use when seeking to understand QSR requirements for device manufacturing.
- Use when assessing HIPAA compliance for connected medical devices or SaMD.
- Use when preparing for an FDA inspection related to quality systems.
非目标
- Providing legal advice or acting as a substitute for legal counsel.
- Performing actual device testing or certification.
- Automating the submission process directly to the FDA.
实践
- Regulatory Compliance
- Quality Management Systems
- Medical Device Development
先决条件
- User needs to provide project directory for documentation analysis.
- Python 3 installed for running utility scripts.
安装
请先添加 Marketplace
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skills质量评分
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