About the Author
Proxima CRO Team
Taylor Lunsford, MGA
Regulatory Associate II
Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

The purpose of Medical Device Reporting (MDR) is that regulation requires medical device manufacturers, device user facilities, and importers to establish a system. The system must ensure the prompt identification, timely investigation, reporting, documentation, and filing of device-related death, serious injury, and malfunction information.

The events described in Medical Device Reports (MDRs) may require the FDA to initiate corrective actions to protect public health.

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