Curriculum
- 5 Sections
- 19 Lessons
- 1 Day
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- Understanding US FDA Regulations4
- Regulatory Pathways & Compliance Challenges5
- 2.1510(k) vs De Novo vs PMA → choosing the right strategy
- 2.2Investigational Device Exemptions (IDE) for clinical studies
- 2.3Combination products and software-driven devices (SaMD, MDSW)
- 2.4Design Control Failures, Inadequate Clinical Evidence, Documentation Gaps, Cybersecurity Non-compliance
- 2.5Enforcement actions: FDA warning letters, import alerts, consent decrees
- Real-Life Case Sharing – Successes & Failures4
- Interactive Exercises & Simulation3
- Wrap-Up & Key Takeaways3
Device classification (Class I, II, III) → key criteria and risk-based logic
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