Re: ISO 13485:2015 Pre-Release News and Discussion
wide dissemination is important not only for getting comments, but also for promoting the planned changes and helping stakeholders brace for impact.
do not worry about it, there will be a consulting army

lined up by than to get additional pennies.
and actually I disagree with you

about the level of involvement of the industry. if we are looking carefully of the involved companies for standardization in general than it is easy to recognise the over representation of such companies those are issuing the vast majority of the recalls.
I also see a thickening gap between standardization and real world with proven good engineering practices to be honest.
Cheers!
