[FREE WHITE PAPER] State of the Art: Establishing a Solid Foundation For Your PERs to Encourage IVDR Readiness
Overview This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it fits into the In Vitro Diagnostic […]
[FREE WEBINAR] Are You Reg. Ready? Get your medical affairs team primed to manage new regulatory requirements.
Click here to watch the webinar Key steps involved in helping medical affairs transition to a more rigorous regulatory environments. How to evaluate talent gaps, team leadership composition, and process […]
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 […]
