IVDR Compliance: Insights Gained from Writing MDR-Compliant CERs that Can Be Leveraged to Meet IVDR Requirements
Author: Suzanne Broussard, PhD | June 8, 2021 In vitro diagnostic (IVD) medical device manufacturers are scrambling to meet the In Vitro Diagnostic Regulation (IVDR) 2017/746 requirements imposed by the European Union (EU). Changes […]
EUDAMED3 Update: Two More Eudamed Modules Will Be Available Later This Year & Guidance on Alternatives Until the Remaining Three Modules are Released and the Database is Fully Functional
Author: Suzanne Broussard, PhD | May 3, 2021 By the end of the year, the first three modules will be accessible on the European medical device database, Eudamed3: Actor Registration, Unique Device Identifiers (UDI)/Device Registration, and Notified Bodies Certificates. […]
[FREE WEBINAR] Leveraging the MDR experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMPF Processes
Click here to watch the webinar Who should watch? All regulatory, clinical, and scientific professionals who are tasked with the development, writing, review or approval of scientific manuscripts, reports, presentations, […]
