ISO 13485:2016 2nd Edition

Unlock the secrets of quality management in the medical device industry with ISO 13485:2016 2nd Edition by Itay Abuhav, published by CRC Press. This essential guide provides a comprehensive exploration of the ISO 13485 standard, essential for organizations aiming to enhance their quality management systems and ensure compliance with regulatory requirements.

In this updated edition, Abuhav offers an in-depth analysis of the revised standard, highlighting the critical changes and their implications for manufacturing and quality assurance processes. The book is structured to facilitate a clear understanding of each clause, making it an invaluable resource for quality professionals, auditors, and regulatory affairs specialists.

Key features include practical insights into risk management, documentation requirements, and best practices for maintaining compliance in a rapidly evolving industry. Abuhav’s expert guidance is complemented by real-world examples and case studies, providing readers with actionable strategies to implement and maintain a robust quality management system.

Whether you are new to ISO standards or looking to deepen your expertise, ISO 13485:2016 2nd Edition is a must-have reference that will empower you to navigate the complexities of the medical device sector with confidence. Elevate your understanding and enhance your organization’s quality practices today!

Note: eBooks do not include supplementary materials such as CDs, access codes, etc.