Achieving ISO 13485:2016 certification demonstrates a commitment to producing safe and effective medical devices. This internationally recognized requirement outlines stringent requirements for quality management systems within the medical device industry. By implementing an ISO 13485:2016 compliant

Six Sigma is a/represents/functions as a data-driven methodology focused on eliminating/reducing/minimizing process errors. By identifying/analyzing/pinpointing the root causes of defects and implementing systematic/structured/rigorous solutions, organizations can achieve significant improvements in