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Human Factors Suite
Quality System Suite
Software Validation Suite
Anesthetic & Respiratory Equipment
General and Miscellaneous
General Aspects of Medical Devices
Healthcare Technology Management (Clinical Engineering)
Implants & Artificial Organs
IT, Software, and Wireless
Quality Systems/Regulatory Affairs
Sterilization - Equipment
Sterilization - Hospital
Sterilization - Industrial
Premarket Risk Management for New Medical Device Companies
Premarket Risk Management
For New Medical Device Companies
If you're part of a new medical device company, this is a must-have book. As a complement to ANSI/AAMI/ISO 14971:2007/(R)2016
Medical devices-Application of risk management to medical devices
, this book explains risk management concepts in practical terms for creating a compliant risk management file for a medical device. You'll learn the risk management activities necessary to device design and development that need to be conducted prior to placing the device on the market. Your company will benefit from having well-structured evidence of risk management activities-necessary to support regulatory submissions, regulatory compliance audits, and compliance testing of the device. The book contains templates for actionable tasks in creating a risk management plan that results in a successful product launch.
The book includes templates for actionable tasks in creating a risk management plan that results in a successful product launch.
[Electronic download of customizable Word templates is provided at the time of purchase. An additional link to these templates is included at the bottom of your order receipt.]
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Tom Shoup, PhD
August 20, 2017
Available for Immediate Download
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