Device Quality Systems Flashcards
——–Standard is the basis of QMS Requirements in the regulations of several countries, and for guidelines developed by GHTF (Global harmonization task force), the rest of this chapter will focus on this standard and related documentation.
ISO 13485
QMS Requirements usually are dependent on the ——-and also depends ————————
1) device risk class
2) regulatory system in the related country or region
In 1996 ISO created an international version, which was the first version of ISO 13485, which was the first version of——-, based on EN 46000
ISO 13485
Although ISO 13485 is the recognized international medical device quality system standard, it is not accepted globally because—-
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——- aims to reduce FDA’s workload if an ISO 13485 compliance audit evaluation has been conducted by the Canadian, Japanese, EU or Australian regulatory agencies
6) Medical device ISO 13485 : 2003 Voluntary Audit Report Submission Pilot Program
Class I manufacturers face no QMS regulatory requirements in ——
Canada
——published a guidance document to assist manufacturers in understanding QMS requirements for process validation.
GHTF (Global Harmonization Task force)
9) Phases of Supplier control—–
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Key Concepts from IMDRF’s Medical Device Single Audit Program (MDSAP) global audit model have been integrated, as has the intent for changes in the upcoming—-
EUMDR
It is important to understand QMS is not required by the EU medical device directives Essential Requirements, but there are QMS requirements in the various possible routes to obtain a —-
CE Mark
——- and —- does not accept ISO 13485 in its Regulatory frame work because it has its own set of QMS Requirements
ANVISA and FDA
—– is one of the Five Medical Device Conformity assessment elements
QMS
