2006

Clinical evaluation of medical devices

2nd ed


 

2008

Combination products : regulatory challenges and successful product developement

Gopalaswamy, Smita.



 

2008

Combination products : regulatory challenges and successful product developement

Gopalaswamy, Smita



 

2009

Design, execution, and management of medical device clinical trials

Abdel-aleem, Salah.



 

2003

Medical device regulations : global overview and guiding principles

Cheng, Michael



 

2002

Medical device safety : the regulation of medical devices for public health and safety

Higson, Gordon R., 1932-2001, author.

Bristol ; Philadelphia : Institute of Physics, ©2002

 

2011

Medical device software verification, validation and compliance

Vogel, David A., author



 

2011

Medical devices and the public's health : the FDA 510(k) clearance process at 35 years

Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process.



 

2010

Public health effectiveness of the FDA 510(k) clearance process : balancing patient safety and innovation : workshop report

 

2011

Public health effectiveness of the FDA 510(k) clearance process : measuring postmarket performance and other select topics : workshop report

 

2005

Six Sigma for medical device design

Justiniano, Jose M