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HEARTACHE BICYCLE TOURING CLUB: TOUR LEADER AND SAG MANUAL March 31, 2015, Tour Director: Bob Rowe (303) 9107230 Tour director heart cycle.org Home Page: www.heartcycle.org This Manual is intended
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Heartcycle is a medical device reporting system used to submit adverse event reports for cardiac devices.
Manufacturers, importers, and device user facilities are required to file reports in heartcycle.
Heartcycle can be filled out online by accessing the FDA's Medical Device Reporting (MDR) portal.
The purpose of heartcycle is to collect and analyze adverse event reports related to cardiac devices in order to monitor their safety and effectiveness.
Information such as the type of device, the adverse event, patient outcomes, and the device manufacturer must be reported on heartcycle.
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