F Fifi2006 Apr 18, 2006 #1 Apr 18, 2006 #1 Hi All, Would anyone be able to supply me with a Gap Analysis of ISO 13485:2003 versus the Japanese’s PAL Ordinance No. 169? Thanks, Fifi.
Hi All, Would anyone be able to supply me with a Gap Analysis of ISO 13485:2003 versus the Japanese’s PAL Ordinance No. 169? Thanks, Fifi.
A Al Rosen Staff member Super Moderator Apr 18, 2006 #2 Apr 18, 2006 #2 Fifi2006 said: Hi All, Would anyone be able to supply me with a Gap Analysis of ISO 13485:2003 versus the Japanese’s PAL Ordinance No. 169? Thanks, Fifi. Click to expand... The best I can do is attach the translation of the law here. It won't be too difficult to do the comparison since the requirements are similar. Attachments mdgmp_qms.pdf 140.5 KB Views: 1,074
Fifi2006 said: Hi All, Would anyone be able to supply me with a Gap Analysis of ISO 13485:2003 versus the Japanese’s PAL Ordinance No. 169? Thanks, Fifi. Click to expand... The best I can do is attach the translation of the law here. It won't be too difficult to do the comparison since the requirements are similar.