Managing the IDE (Investigational Device Exemption) Submission for Compliance Success 2016 is a webinar that covers topics such as:
- 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
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success 2016 is intended for attendees from:
- Clinical Affairs
- Regulatory Affairs
- Marketing & Sales
- Quality and Compliance
- Engineering/Technical Services/Operations
- Distributors/Authorized Representatives
- Consultants
