I. Introduction A. Brief Overview of ISO 13485 Certification ISO 13485 Certification is an internationally recognized standard that outlines the requirements for a quality management system (QMS) in the medical device industry. It focuses on ensuring that organizations establish and maintain processes that consistently produce safe and effective medical devices. Compliance with ISO 13485 demonstrates a commitment to quality, regulatory compliance, and customer satisfaction. B. Importance of ISO 13485 Certification ISO 13485 Certification is pivotal in the medical device industry, serving as a global standard for quality management systems. This certification ensures regulatory compliance, elevates product safety and quality, and…