ISO 13485 certification is an international standard that specifies requirements for a quality management system specific to the medical device industry. It ensures that organizations consistently meet customer and regulatory requirements related to the design, production, and distribution of medical devices. Achieving ISO 13485 certification demonstrates a company’s commitment to product safety, quality, and compliance with global healthcare regulations. This certification can enhance market access, improve risk management, and build trust with regulators and customers in the medical field.