Postmarket device safety monitoring

Author:

Bitterman Danielle S.,Wunnava Susmitha

Publisher

Elsevier

Reference32 articles.

1. Center for Devices & Radiological Health, U.S. Food and Drug Administration. Medical Devices. https://www.fda.gov/medical-devices. Accessed January 29, 2022.

2. Postmarketing surveillance of medical devices--filling in the gaps;Resnic;N Engl J Med,2012

3. MAUDE - Manufacturer and User Facility Device Experience. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/. Accessed January 25, 2022.

4. Postmarket medical device safety: moving beyond voluntary reporting;Resnic;BMJ Qual Saf,2018

5. Reporter's occupation and source of adverse device event reports contained in the FDA's MAUDE database;Kavanagh;Patient Relat Outcome Meas,2019

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