Handbook of Medical Device Design

Biocompatibility Software verification Customer needs SRS Medical Device Design Medical device Medical Device Regulation North american free trade agreement Institutional Review Board Premarket Notification AIMDD configuration items Device Master Records EU Medical Device Directive FDA regulations Class Ii Device Conformity Assessment Procedure Functional configuration audit GMP Regulation Global Harmonization Task Force Device History Record Medical Device Software GMP Inspection Safe Medical Device Act safety/risk analysis Software Fault Tree Analysis SQAP medical device directives QS Regulation Weibull Plotting