[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 […]
[FREE WEBINAR SERIES] How to Assess Your CER for MDR Readiness
In the first installment of this webinar series, Criterion Edge presents strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR […]
