<P> The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the ISO 13485 standards and the US FDA 21 CFR 820 regulations . The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines . </P> <P> ISO 13485 are harmonized with the European Union medical devices directive (93 / 42 / EEC) as well as the IVD and AIMD directives . The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS). </P> <P> Quality System requirements for medical devices have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983 and were instituted as requirements in a final rule published on October 7, 1996 . The U.S. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place . The rule is promulgated at 21 CFR 820 . </P> <P> According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation . As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements . </P>

Compliance to all quality norms as per qms