MASAMUNE Ken
Department Graduate School of Medical Science, Graduate School of Medical Science Position Professor |
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Article types | Original article |
Language | English |
Peer review | Peer reviewed |
Title | Assessment of Regulatory Compliance Issues Involving Reprocessing of Single-Use Devices in the United States |
Journal | Formal name:Pharmaceutical and medical device regulatory science ISSN code:18846076 |
Domestic / Foregin | Domestic |
Volume, Issue, Page | 46(11),pp.788-796 |
Author and coauthor | MATSUMOTO Toru†, MATSUMOTO Keisuke, NAKAZAKI Tomomichi, ISEKI Hiroshi, MASAMUNE Ken |
Publication date | 2015/11 |
Summary | PDF Not find!
Single-Use Device (SUD) Reprocessing 510 (k) Quality System Regulation (QSR) Recall Design change U.S. Food and Drug Administration (FDA) |
NAID | 40020653408 |