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ISO13485:2003 vs. the Japanese PAL Ordinance No. 169 - Seeking Gap Analysis

F

Fifi2006

#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.
 

Al Rosen

Staff member
Super Moderator
#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.
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.
 

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