iso 13485 certification

ISO 13485 certification is an international standard that specifies requirements for a quality management system (QMS) specific to the medical device industry. It ensures that organizations consistently design, produce, and deliver medical devices that meet regulatory and customer requirements. This certification demonstrates a company’s commitment to quality and patient safety, helping to build trust with regulators, healthcare providers, and patients. Achieving ISO 13485 certification is often essential for market access in many countries and supports compliance with global regulatory frameworks.