マサムネ ケン   MASAMUNE Ken
  正宗 賢
   所属   医学研究科 医学研究科 (医学部医学科をご参照ください)
   職種   教授
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 / ForeginDomestic
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