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


Fifi2006
18th April 2006, 08:56 AM
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
18th April 2006, 10:01 AM
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.