ISO 13485 in Mexico

Sat, 18 Jan 2025 06:05:09 +0000

A. Overview of ISO 13485 CertificationISO 13485 is the international standard for quality management systems in the medical device industry. It outlines the requirements for organizations involved in designing, manufacturing, and distributing medical devices. In Mexico, compliance with ISO 13485 is critical for accessing domestic and global markets, ensuring product safety and customer satisfaction.