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Volume 7 · Issue 11 · November 2002


Page 32…

Medical Devices QMS Standard Elevated to FDIS

Despite an effort by three European countries to obtain its full alignment, ISO 13485 was elevated to FDIS status with only partial alignment of the medical devices sector QMS requirements standard with ISO 9001:2000. Information on the TC 210 WG 1 meeting that addressed the DIS comments is included.