The DIY Clinical Evaluation Report – Do You Really Need A CER Writer?
So you’ve taken a look at EU MDR transitions for some of your devices [...]
CER Writer | How to Find The Best CER Medical Writers & Strategy
Are you shopping for CER writers? Or perhaps trying to evaluate if this is [...]
Before You Hire a Clinical Evaluation Consultant: Read This
Thinking of Hiring a Clinical Evaluation Consultant? So it's finally time to either start [...]
CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements
The European Union Medical Device Regulation (EU MDR) has set higher standards for medical [...]
Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be continuously monitored to confirm its [...]
CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by bit every day, and one [...]
Five Practical Tips for Writing a Compliant Clinical Evaluation Report (CER)
Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report [...]
Managing Clinical Evaluation Report (CER) and Literature Review Teams
Being a medical device manufacturer involves more than the actual manufacturing of the medical [...]