Risk-Based Quality Management in Healthcare Organization: A Guide based on ISO 13485 and EU MDR

Dr. Akash Sharma; Ms. Vriti Gamta; Mr. Gaurav Luthra

ISBN 13: 9798890665249

Published by Notion Press, 2023

About this Item

Seller Inventory # I-9798890665249

Bibliographic Details

• Title: Risk-Based Quality Management in Healthcare Organization: A Guide based on ISO 13485 and EU MDR
• Publisher: Notion Press
• Publication Date: 2023
• Language: English
• ISBN 13: 9798890665249
• Binding: Soft cover
• Condition: New

About this title

Synopsis

"Risk-Based Quality Management in Healthcare Organization: A Guide based on ISO 13485 and EU MDR" is a comprehensive handbook that offers practical guidance for healthcare professionals to excel in risk-based quality management. It explores the regulatory landscape of the healthcare industry, emphasizing ISO 13485 and EU MDR as the foundation. The book provides a step-by-step approach to implementing effective risk assessment and mitigation strategies, ensuring compliance with international standards. It includes best practices to navigate risk management throughout the medical device lifecycle. The guide also addresses integrating risk management into existing quality management systems, conducting audits, and meeting EU MDR requirements. By mastering the principles in this guide, professionals can enhance patient safety, improve product quality, and achieve regulatory compliance. It is a valuable resource for healthcare professionals involved in device design, manufacturing, testing, and regulatory affairs.