IATF 16949:2016 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the IATF 16949:2016 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. Adopting IATF 16949:2016 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.