Are you prepared for the new IVDR?
As you might know the new IVDR, coming into force on May 2022, will have major implications on your operations. The need of a notified body for app. 80% of products, even for existing ones, and the assignment of a Person Responsible for Regulatory Compliance (PRRC) are only some of them. We at Expand Healthcare Consulting together with one of our partners have successfully mastered similar situations with our medical device clients – preparing for the change from MDD to MDR. Now, facing the upcoming challenges of the new IVDR, we have already bolstered our capacity and partnered with Expand Healthcare…