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

• Main Authors: Soo Jeong Choi (Author), Sooin Choi (Author), Songhyeon Park (Author), Ki Chang Nam (Author), Hye Jung Jang (Author), Jin Kuk Kim (Author), You Kyoung Lee (Author), Hiroshi Ishikawa (Author), Eric Woo (Author)
• Format: Book
• Published: BMC, 2024-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...