I am an engineer for a small (<50 employees) medical device manufacturing plant. I am currently working on an R&D project that will be ultimately affected by this updated revision of ISO13485:2015. (according to BSI white pages) Normally a Gap Analysis would be the general course of action for me/us to take to ensure compliance, however; here is the situation - Our NB has indicated that we will be audited on both the ISO13485:2012 (amendments) and ISO13485:2015 this fall and the ISO13485:2015 revision is to be released in the fall. My question is; where is the time needed to complete any gap analysis especially if we are audited prior to the release of 2015 revision? I feel this is just another way for NB's to buckle-up small medical device manufacturers. Does anybody have any direction for me on my situation? Thanks.