2020

Medical device cybersecurity for engineers and manufacturers

Wirth, Axel (Security strategist), author.

Norwood, MA Artech House [2020]

 

2019

Data integrity and compliance : a primer for medical product manufacturers

Rodríguez Pérez, José, 1961- author.

Milwaukee, Wisconsin : ASQ Quality Press, [2019]

 

2019

Equipment qualification in the pharmaceutical industry

Ostrove, Steven A., author.

London : Academic Press, [2019]

 

2018

Handbook of medical device regulatory affairs in Asia

Second edition
Singapore : Pan Stanford Publishing, [2018]

 

2017

Sterilization validation & routine operation handbook (2001) : radiation

Booth, Anne F., author.
First edition
Boca Raton, FL : CRC Press, 2017

 

2017

Bioprocessing piping and equipment design : a companion guide for the ASME BPE standard

Huitt, William M., 1943- author.

Hoboken, New Jersey : John Wiley & Sons, Inc., [2017]

 

2015

Medical devices : regulations, standards and practices

Ramakrishna, Seeram, author.

Cambridge : Woodhead Publishing, an imprint of Elsevier, [2015]

 

2013

Engineering controls and work practice controls

 

2013

Handbook of medical device regulatory affairs in Asia

 

2013

Medical devices : surgical and image-guided technologies

Hoboken, N.J. : Wiley, a John Wiley & Sons, Inc., publication, [2013]

 

2013

Reliable design of medical devices

Fries, Richard C.
3rd ed


 

2012

ISO 13485 : a complete guide to quality management in the medical device industry

Abuhav, Itay



 

2011

Health care comes home : the human factors

National Research Council (U.S.). Committee on the Role of Human Factors in Home Health Care.

Washington, D.C. : National Academies Press, [2011]

Request It 

2011

Health care comes home : the human factors

National Research Council (U.S.). Committee on the Role of Human Factors in Home Health Care.



 

2011

Safety evaluation of pharmaceuticals and medical devices : international regulatory guidelines

Gad, Shayne C., 1948-



 

2011

Medical device design and regulation

DeMarco, Carl T., author

Milwaukee, Wisconsin : ASQ Quality Press, 2011

 

2011

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

 

2010

Medical devices : managing the mismatch : an outcome of the Priority Medical Devices project

World Health Organization



 

2010

Biomedical technology assessment : the 3Q method

Weinfurt, Phillip T. (Phillip Thomas), 1941-



 

2010

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

 

2009

Design, execution, and management of medical device clinical trials

Abdel-aleem, Salah.



 

2009

The medical device industry : developments in software risk management

Burton, John



 

2009

Ballistic resistance of body armor

New York : Nova Science Publishers, Inc., [2009]

 

2009

Medical technology into healthcare and society : a sociology of devices, innovation and governance

Faulkner, Alex, 1952-



 

2008

Medical Device Design for Six Sigma : a Road Map for Safety and Effectiveness

El-Haik, Basem



 

2008

The FDA and worldwide quality system requirements guidebook for medical devices

Daniel, Amiram
2nd ed


 

2008

FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics

2nd ed


 

2008

Combination products : regulatory challenges and successful product developement

Gopalaswamy, Smita.



 

2008

Combination products : regulatory challenges and successful product developement

Gopalaswamy, Smita



 

2007

Guide to microbiological control in pharmaceuticals and medical devices

Denyer, S. P.
2nd ed


 

2006

Safe medical devices for children

Institute of Medicine (U.S.). Committee on Postmarket Surveillance of Pediatric Medical Devices.
First edition
Washington, D.C. : National Academies Press ; Oxford : Oxford Publicity Partnership [distributor], 2006

Request It 

2006

Safe medical devices for children

Institute of Medicine (U.S.). Committee on Postmarket Surveillance of Pediatric Medical Devices.



 

2006

Clinical evaluation of medical devices

2nd ed


 

2006

Reliable design of medical devices

Fries, Richard C
2nd ed


 

2005

Six Sigma for medical device design

Justiniano, Jose M



 

2004

FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics

 

2003

Medical device regulations : global overview and guiding principles

Cheng, Michael



 

2003

Design controls for the medical device industry

Teixeira, Marie B., 1965-



 

2003

Practical design control implementation for medical devices

Justiniano, Jose M.



 

2002

Design of medical electronic devices

Perez, Reinaldo.



 

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

 

2000

Medical device reliability and associated areas

Dhillon, B. S. (Balbir S.), 1947-



 

1998

Medical device quality assurance and regulatory compliance

Fries, Richard C



 

1998

Medical device packaging handbook

2nd ed., rev. & expanded


 

1995

Materials for saline water, desalination and oilfield brine pumps

2. ed


 

1992-

Medical device approval letter : the monthly guide to getting 510(k)s and PMA applications approved

 

1983

FDA inspection operations manual : for drugs, devices, & cosmetics

United States. Department of Health and Human Services.



 

 

Journal of GXP compliance

Royal Palm Beach, FL : Institute of Validation Technology

 

 

Journal of validation technology

Norwalk, CT : Training Dynamics

 

2023

Above ground storage tank oil spills : applications and case studies

Cambridge, MA : Gulf Professional Publishing, an imprint of Elsevier, 2023