Regarding harmonization, and particularly harmonization of US FDA QSR and EU rules...is that specifically an issue for this ISO 13485 revision cycle?.
Issue? Not at all, but we are talking two different levels of harmonization here. ISO 13485 has always been aligned with the EU requirements and also with the FDA requirements for quality systems. And it will remain aligned (I commented something on the history of this in this post - http://elsmar.com/Forums/showpost.ph...90&postcount=6
) - there´s still some different points that will be corrected in the revision. This does not mean that the requirements are the same, but they require the same thing and if correctly applied the quality system will fulfill both. It also does not mean that FDA will dump one in favor of the other - the second level of harmonization, let´s say.
But, from what I´ve heard (and I also do not know the full politics of the agency) yes, there´s historically been somewhat of a fight of understandings regarding harmonization, and there´s a lot of different views on the subject.