Managing the IDE (Investigational Device Exemption) Submission for Compliance Success 2016

Topics

• The application process and administrative action with your IDE
• The appropriate and expected regulatory strategies and guidelines for your IDE
• IRB review and approval and expectations
• The responsibilities of the sponsor
• IDE refers to the regulations under 21 CFR 812
• What records and reports are expected and required
• Understand that if the study involves a significant risk device, the IDE must also be approved by FDA
• Procedures involved with the clinical studies and expectations

Who should Attend

Attendees from:

• Clinical Affairs
• Regulatory Affairs
• Marketing & Sales
• Quality and Compliance
• Engineering/Technical Services/Operations
• Distributors/Authorized Representatives
• Consultants