There’s so much change going on right now, with the upgrade to ISO 13485:2016 and the transition to the new European regulations creating headaches for us all. What is notable about all of this is how much of the change is now focused on the postmarket world – i.e. requirements to ensure continuing compliance and safety once the product is approved for marketing. For sure there are updates to document requirements for conformity assessment, but the biggest changes in both ISO 13485 and the EC Regulation are all about active vigilance. It’s no longer enough to just keep a weather eye on customer complaints.
In this new world manufacturers are expected to actively monitor their devices in the market place – including specific expectations for periodic reviews of clinical evidence and active postmarket clinical follow up for higher risk devices. In this Webinar, we take a look at how to stay constantly alert – without losing too much sleep
Join Arthur Brandwood, Principle Consultant to take a closer look at the changes in the upgrade to ISO 13485:2016 and the transition to the new European regulations.Download PPT Slides Contact Us