CHICAGO, IL (September 23, 2020) — Treximo, a leading global life sciences consulting and solutions provider and part of The Planet Group, announced today the kick off of a multi-part training program to help manufacturers transition from the current MDD / IVDD regulatory framework in Europe to MDR / IVDR.
With the compliance dates for the European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) quickly approaching, Treximo’s series will cover a wide variety of pertinent subjects applicable to the device / diagnostics industries as they relate to the change in the regulatory framework in Europe.
Part one of the series will be held on Wednesday, October 7th at 11 a.m. EST (10 a.m. CST) and will focus on “Avoiding Clinical Pitfalls on the Path to MDR Compliance.” Treximo’s Senior Vice President of Device and Diagnostics Ronald Freeze and Senior Director of Device and Diagnostics Writing Belinda Larson will host the online training. The session will focus on equivalency, the impact of Basic UDI-DI Compliance and the definition of state of the art with consideration to the large number of guidance documents that continue to be published in this space. In addition, the need for a robust clinical strategy and what that looks like will be discussed.
Part two of the series is Tuesday, November 10th. The topic is “Understanding the Concept of a CEP in the Context of MDR.”
For more information about the series, or to register for a session, visit https://treximo.com/mdr-transition-training-program.
Treximo, part of The Planet Group, is a global consulting and solutions partner to industry-leading Biotech, Pharmaceutical, Medical Device and Diagnostic companies. Headquartered in Chicago, Illinois, quality is at the heart of everything we do. We ensure risk assessment, clinical evaluation, compliance and manufacturing improvement at every turn. Read more about our approach to EU MDR and EU IVDR Implementation here.