<prompt> Translate the following text to EnglishMfumo wa ubora wa vifaa vya matibabu una mahitaji yanayohusiana na mbinu zinazotumiwa, vifaa na udhibiti unaotumiwa kwa kubuni, kutengeneza, kufunga, kuweka alama, kuhifadhi, kufunga na huduma ya vifaa vya matibabu vilivyokusudiwa kutumiwa na binadamu.  <response>: The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices intended for human use. 