Risk-Based Thinking in ISO 13485 Implementation

Maintaining safety and quality is of the utmost importance in the constantly shifting world of medical equipment manufacturing. Let me present ISO 13485, an internationally recognized standard that outlines requirements for a quality management system, or QMS, tailored for the healthcare sector. Among all of its components, risk-taking is one that sticks out as essential. The paper explores the role that risk-based reasoning plays in the implementation of ISO 13485 and how it impacts the manufacturing environment for medical devices.