Transcription of The new U.S. FDA regulations on biocompatibility …
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The new U.S. FDA regulations on biocompatibility …
The new FDA regulations on biocompatibility and reprocessing for medical devices Wissenschaftliche Pr fungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen Fakult t der Rheinischen Friedrich-Wilhelms-Universit t Bonn vorgelegt von Anna Reifschneider aus Togliatti Bonn 2017 Page ii Betreuer und 1. Referent: Dr. Birka Lehmann 2. Referent: Dr. Ehrhard AnhaltPage iii Table of ContentsTable of Contents 1 List of Abbreviations .. vi 2 Introduction .. 1 3 The FDA regulations on premarket submissions ( , 510(k) and PMA) .. 3 4 Regulatory and quality failures have been the precursor for most FDA guidances .. 4 5 How the QSR affects biocompatibility , reprocessing , and sterilization .. 7 6 biocompatibility .. 9 General .. 9 History of biocompatibility and the FDA .. 9 biocompatibility requirements for medical devices .. 10 General principles for biocompatibility testing on medical devices.
The new U.S. FDA regulations on . biocompatibility and reprocessing for medical devices . Wissenschaftliche Prüfungsarbeit . zur Erlangung des Titels
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