2012

Development of FDA-regulated medical products : a translational approach

Whitmore, Elaine, author.
Second edition
Milwaukee, Wisconsin : ASQ Quality Press, 2012

 

2008

The FDA and worldwide quality system requirements guidebook for medical devices

Daniel, Amiram
2nd ed


 

2011

Medical device design and regulation

DeMarco, Carl T., author

Milwaukee, Wisconsin : ASQ Quality Press, 2011

 

1998

Medical device quality assurance and regulatory compliance

Fries, Richard C



 

2003

Medical device regulations : global overview and guiding principles

Cheng, Michael



 

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