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NEW MEDICAL DEVICE MONITORING FORM Complete, obtain approval and send (electronic) to Clinical Engineering or (hard copy) fax to 924-1286 or mail to Box
 

Summary: NEW MEDICAL DEVICE MONITORING FORM
Complete, obtain approval and send (electronic) to Clinical Engineering or (hard copy) fax to 924-1286 or mail to Box
800700). Your request will be routed for internal processing. The status of your request can be monitored on the O shared
drive in the folder Meddev.
Section A: Requestor Information (required)
Requestors' Name: Request Date:
Need Date:
Dept/Division: Box #: Phone #: FAX #:
List other users beside your requesting Dept/Division that will be affected by the request:
Section B: New Supply/Equipment Information (required)
Product Name: Model/Catalog #:
Manufacturer: Vendor: Contact Phone #:
Packaging Unit (e.g. each, box, case): Cost/Unit: Estimated annual usage:
If equipment, list accessories/supplies needed:
Description of use:
If Evaluation : start date end date
Is request for a new investigational device? Yes No Not applicable
If yes, is a letter on file from the manufacturer stating FDA classification? Yes, indicate location_____________ No
Has the IRB for Health Sciences Research approved the project? Yes(send copy) No Not applicable
Section C: Impact to patient care (required)

  

Source: Acton, Scott - Department of Electrical and Computer Engineering, University of Virginia

 

Collections: Computer Technologies and Information Sciences