For medical device managers, it is that time of the year when precautions should be especially considered. Medical products have international standards which must be complied with if these devices are to be internationally used and shipped. Most importantly, understanding and complying with ISO 14971 and its most recent version is necessary, and you must be prepared to lead your team in a risk evaluation that follows these standards. But first, what are the standards of the ISO 14971:2012 exactly, and what is it all about? Read more »