top of page


4 min read
Is it a DHF, Medical Device File or Technical File?
Medical Device File is a term used by ISO 13485, similar but different than a DHF and a Technical File for EU Submission


2 min read
A Comprehensive Guide to Clinical Evaluation Reports (CERs) for EU MDR Compliance
Welcome back to our blog series focusing on EU MDR compliance strategies. In our previous post, we highlighted the importance of Clinical...


2 min read
Mastering Clinical Evaluation for EU MDR Compliance: A Summary Guide
Delving into one crucial aspect of EU MDR compliance: Clinical Evaluation
bottom of page