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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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NOTE: This document is only available for preorder in print format and is still in production. Credit cards are the only form of payment accepted with preorders, and will be charged at the time of purchase.
Product Code:
PRM
Author:
Tom Shoup, PhD
Date:
August 20, 2017
ISBN Number:
978-1-57020-672-6
Pages:
118
Available for Immediate Download
Standards Formats
Currently Selected: Print
AAMI Member:
$110.00
List Price:
$144.00
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