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Mastering Safety Risk Management for Medical and In Vitro Devices - by Jayet Moon & Arun Mathew (Paperback)

Mastering Safety Risk Management for Medical and In Vitro Devices - by  Jayet Moon & Arun Mathew (Paperback) - 1 of 1
$64.99 sale price when purchased online
$70.00 list price
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About this item

Highlights

  • When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment.
  • Author(s): Jayet Moon & Arun Mathew
  • 306 Pages
  • Business + Money Management, Auditing

Description



Book Synopsis



When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product's life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).
Dimensions (Overall): 9.0 Inches (H) x 6.0 Inches (W) x .64 Inches (D)
Weight: .91 Pounds
Suggested Age: 22 Years and Up
Number of Pages: 306
Genre: Business + Money Management
Sub-Genre: Auditing
Publisher: ASQ Quality Press
Format: Paperback
Author: Jayet Moon & Arun Mathew
Language: English
Street Date: May 10, 2024
TCIN: 94346702
UPC: 9781636941707
Item Number (DPCI): 247-24-8485
Origin: Made in the USA or Imported
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Shipping details

Estimated ship dimensions: 0.64 inches length x 6 inches width x 9 inches height
Estimated ship weight: 0.91 pounds
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