[FREE WEBINAR] Hidden Traps That Derail PER Preparedness: Lessons Learned from the MDR-Compliant CER Writing Experience
Click here to watch the webinar Who should watch this webinar? Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval […]
[FREE WEBINAR] Hidden Traps That Will Derail Your CER: Answer these critical questions before you start writing
Click here to watch the webinar As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER. This takes more […]
Notified Bodies Received New Guidance from MDCG on the Use of MDSAP Audit Reports for MDR and IVDR
Author: Dr. Suzanne Broussard | September 28, 2020 Medical device manufacturers received clarification on how the European Commission’s Medical Device Coordination Group (MDCG) will allow Notified Bodies (NBs) to use Medical Device Single Audit Program […]
