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University of Michigan - MIAP Medical Devices in Academic Research Training and Symposium


Regulatory Affairs Professional Society (RAPS) 2-day Training

Monday, October 14 & Tuesday, October 15

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.

RAPS 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.

DAY 1 AGENDA >

DAY 2 AGENDA >

Attendance is free to members of CTSA hubs. Registration is limited to 30 participants on a first-come first-served basis.

Register here for RAPS Training: MedicalDevicesinAcademicResearchCTSA.splashthat.com

Wednesday, October 16 U-M Symposium

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

Register here: MedicalDevicesinAcademicResearchSymposium.splashthat.com