C
C Logan
I am looking for a comparison guide like the GD210, which compares ISO13485:2003 to SOR/98 - 282, only comparing ISO 13485:2003 to the 93/42/EEC Medical Device Directive.
Anyone have clues if there is something comparable out there? I need to do a GAP analysis between our current QMS and what would require tweaking for the EEC standard.
Any help would be greatly appreciated.
Anyone have clues if there is something comparable out there? I need to do a GAP analysis between our current QMS and what would require tweaking for the EEC standard.
Any help would be greatly appreciated.