Volume 7 · Issue 11 · November 2002
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.