Topics will include but are not limited to:

• Regulatory definition of medical devices.
• Overview of medical device product types
• The FDA’s role and responsibilities in the regulation and oversight of medical devices
• Regulatory history
• Device classification system
• Clearance process and inspection
• Enforcement
• Comparison of 21 CFR 820 (QSR) to ISO 13485

Learning Objectives include:

• Explain the regulatory definition of medical devices
• Describe the FDA regulation of medical devices
• Identify aspects of FDA oversight
• Discuss  Quality Systems Regulations
• Compare and contrast  ISO 13485 and QSR
• Discuss the mechanics of ISO certification
• Implement Good Documentation Practices
• Search the FDA website and resources