Developed by the International Organization for Standardization (ISO), ISO 13485 is the internationally recognized standard for quality management systems specific to medical devices. This comprehensive standard outlines the requirements for a robust quality management system, encompassing all stages of a medical device's lifecycle, from design and development to production, distribution, and post-market surveillance. By adhering to ISO 13485, medical device manufacturers demonstrate their commitment to a quality-centric culture, ensuring the safety, efficacy, and reliability of their products.