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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…
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cMyC is providing value when ruling out Myocardial infarction (MI)

The latest ESC guideline, published 29th of August 2020, was one of the highlights of the ESC online Congress 2020.  Some significant changes regarding the use biomarkers are to be noted, including that cardiac Myosin-binding protein C (cMyC) is now part of the guideline. Here is a key excerpt (Section 3.3.2.2): “Among the multitude of additional biomarkers evaluated for the diagnosis of NSTE-ACS, only CK-MB, myosin-binding protein C, and copeptinmay have clinical relevance in specific clinical settings when  used in combination with cardiac troponin T/I. Compared with cardiac troponin, CK-MB shows a more rapid decline after MI and may provide added value for the timing of…
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