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 […]
[FREE WEBINAR] Hidden Traps That Derail PER Preparedness: Lessons Learned from the MDR-Compliant CER Writing Experience
Click here to watch the webinar Key Takeaways:•The importance of scoping your PER project in advance•The critical inputs needed to enable the success of your PER and the impact to […]
