If the MDD to MDR transition wasn’t enough for us to deal with, we also have ISO 13485:2016, which is currently about half way through its three-year transition period, ending in March 2019. On the surface, the changes from the current 2012 harmonised version of this standard may seem minimal, but the devil is in the detail, and there are quite a few new requirements for manufacturers to deal with.

Risk Management appears more than a few times, along with the old favourite Change Control. More detail around software validation and increased emphasis on vendor control will all add to the documented requirements, as well as the knock-on effects of training, implementation and management.

For anything from a quick gap analysis, to a full blown QMS re-write, get in touch to see how we can help you.