As we move closer to the May 2022 deadline where all IVD products marketed in the EU must meet the new IVDR regulations, it is imperative for manufacturers to begin the process of implementing the mandated requirements.
To help manufacturers navigate this complex landscape, Karin Hughes, PhD, Senior Vice President, Regulatory & Quality, delivered a presentation during the 14th Annual IVD Clinical & Regulatory Affairs Conference in October, 2020. This webinar, Ensuring Compliance with IVDR Clinical Requirements, covers considerations and best practices across the following topics:
- Developing clinical evidence reflective of a European population
- Establishment of scientific, clinical, & analytical validity
- Implementation of a risk based post market surveillance system
- Confirming the IVD test adheres to “state of the art” definition
Beaufort can support all facets of your IVDR implementation. Our team of IVDR subject matter experts have an in-depth understanding of the complex details, regulatory expectations and new mandatory requirements. We provide the strategic and technical guidance to develop an appropriate project plan, as well as assist with the implementation of any stage of the IVDR certification process.
Beaufort CRO was proud to sponsor the 14th Annual IVD Clinical & Regulatory Affairs Conference in October, 2020, and partner with Q1 Productions on this important industry event.