The application study of harmonization code in medical device adverse event reporting

The application study of harmonization code in medical device adverse event reporting

Abstract Background The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international r...

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Bibliographic Details
Main Authors: Soo Jeong Choi, Sooin Choi, Songhyeon Park, Ki Chang Nam, Hye Jung Jang, Jin Kuk Kim, You Kyoung Lee, Hiroshi Ishikawa, Eric Woo
Format: Article
Language:English
Published: BMC 2024-11-01
Series:BMC Health Services Research
Subjects:
Medical devices
Safety management
Adverse event
Post-market surveillance
IMDRF
International medical device regulators forum
Online Access:https://doi.org/10.1186/s12913-024-11885-1
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