As far as standards go, ISO 14971:2000 is a great standard. So much so, that basically everyone in the world recognizes this standard as THE standard for medical device risk management.
ISO 14971 was recently revised in March 2007. I have not had an opportunity to review this revision in detail but have heard great things so far. From what I understand, the basic language within the standard has remained in tact. The improvements are within the annexes. This brief article from Medical Product Outsourcing provides a little more insight. Do any of you have insight on ISO 14971:2007 that you’d like to offer?
Coincidentally, the Midwest Discussion Group will be tackling Risk Management starting with the August 30, 2007 meeting. A likely subtopic will be comparing and contrasting the 2000 and 2007 versions.