ISO 13485

Mon, 13 Jan 2025 05:29:30 +0000

I. Introduction to ISO 13485 in PeruA. Overview of ISO 13485ISO 13485 is an international standard that outlines the requirements for a comprehensive quality management system (QMS) specifically for medical devices. It is applicable to all stages of a product’s lifecycle, including design, production, installation, and servicing. The certification ensures that organizations can consistently produce medical devices that meet regulatory requirements and are safe for consumers. In Peru, the significance of ISO 13485 has grown as the country focuses on improving healthcare standards and device safety. This section introduces the key concepts behind ISO 13485 and its global and local relevance.