ISO 13485:2016 Medical devices - QMS: Practical Guide

Tailored for quality managers, regulatory professionals, and organizational leaders, the guide covers all critical aspects of ISO 13485 compliance, from initial implementation to maintaining certification. With detailed chapters on risk management, corrective and preventive actions (CAPA), internal audits, and document control, readers will gain the tools and insights needed to ensure product quality and regulatory adherence. Real-world case studies, practical examples, and actionable checklists support each section, making this guide an essential resource for navigating ISO 13485 requirements effectively and fostering a culture of quality and compliance in medical device manufacturing.