ISO 13485 is an international standard that specifies requirements for a quality management system specific to the medical device industry. In Argentina, ISO 13485 certification is especially important for companies involved in the design, production, and distribution of medical devices, as it ensures compliance with both international and local regulatory requirements. Achieving this certification demonstrates a commitment to product safety, quality, and consistency, which can enhance trust with healthcare providers, regulators, and patients, while also facilitating access to global markets.