Medical devices drive clinical care, whether in the form of a surgeon’s scalpel, a simple blood test, or a complex imaging machine. With the technological innovation and advances made in precision medicine, 3-D printing, and mobile medical applications, these devices are now a large part of the research landscape.
As the rapid advances in technology outpace changes in regulation, FDA oversight and the regulatory requirements have become more challenging. Join us for this three-day event to get the information you need to advance your regulatory expertise.
Trainer: Tony Blank
RAPS (Regulatory Affairs Professional Society) will provide a 2-day, Investigational Device Exemption (IDE) Submission Workshop specific to academic research. Sessions will include developing an IDE strategy, preparing for and conducting Pre-Submission meetings, and preparing and submitting an IDE application.
All participants are also invited to attend the U-M Medical Devices in Academic Research symposium on Wednesday, October 16. Topics include:
• Regulatory Challenges in Precision Medicine
• Design Controls
• Medicare Reimbursement
• Digital Health and the use of Artificial Intelligence
Full agenda coming soon
Attendance is free to members of CTSA hubs. Registration is limited to 30 participants on a first-come first-served basis.
If you are unable to attend this workshop, please cancel your registration to release a seat for those on the wait list. If your cancellation is not received at least two weeks prior to the workshop, your department will be billed a $50.00 cancellation fee.
• The elements of an IDE
• Use of standards (e.g., ISO, ANSI, AAMI, etc.)
• Protocols, records, reports
• Avoiding common errors and deficiencies
• Key elements to the study protocol
• The role of risk analysis in the IDE
• Managing planned or unplanned device or study changes
• Reimbursement for clinical studies
Attendance is free to members of CTSA hubs. Registration is limited to 30 participants on a first-come first-served basis.
If you are unable to attend this workshop, please cancel your registration to release a seat for those on the wait list. If your cancellation is not received at least two weeks prior to the workshop, your department will be billed a $50.00 cancellation fee.