Quality Risk Management in the FDA-Regulated Industry

by Josae Rodraiguez Paerez and José Rodríguez-Pérez

The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which...

• Format: Hardcover
• Language: English
• ISBN: 0873899482
• ISBN13: 9780873899482
• Release Date: February 2017
• Publisher: ASQ Quality Press
• Length: 362 Pages
• Weight: 1.44 lbs.
• Dimensions: 0.8" x 6.0" x 9.0"