Managing the IDE (Investigational Device Exemption) Submission for Compliance Success 2016
01 Dec 2016
Webinar
Key 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
Past Events
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success 2016 - 01 Dec 2016, Webinar (63686)
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success 2026
Important
Please, check "Managing the IDE (Investigational Device Exemption) Submission for Compliance Success" official website for possible changes, before making any traveling arrangements
