The word “quality” is synonymous with medical, pharmaceutical and diagnostic device design, development and manufacturing. Government and third-party organizations, as well as more than 1,400 International Organization for Standardization (ISO) standards, focus on ensuring consistency, quality and safety.1 Those numbers, however, don’t include critical certifications and registrations to which these companies also must adhere, such as current Good Manufacturing Practice (cGMP), European Union Medical Device Regulation (EU) No. 2017/745, Medical Device Single Audit Program (MDSAP), National Medical Products Administration (NMPA), and Ministry of Health, Labour and Welfare (MHLW). 

While most healthcare device companies can point to their list of certifications and registrations, these represent the bare minimum of what a healthcare company must do to meet the industry standards for quality. For a quality commitment to be truly authentic in healthcare, it must be all encompassing and reflected in the organization’s vision, values, culture, employees, products and services.