MedTech Compliance Articles
Expert guides on EU MDR, Clinical Evaluation, and Literature Review strategies.
CiteMed | EU MDR & Clinical Evaluation Insights
In-depth articles and resources on EU MDR, IVDR, and clinical evaluation for regulatory affairs professionals.
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Clinical Evaluation Assessment Report Rubric: What Does It Mean For Your MDR Submissions?
MDCG’s Guidance document, released in July 2020, introduces and [...]
Classifying In Vitro Diagnostic Medical Devices Under The MDR
May 26, 2022, marks the start of the 5-year [...]
Fundamentals of a Literature Review: A Beginner’s Guide
The medical device industry is fueled by innovation. Research [...]
EU MDR: Combination Products – An Overview
We all know and love (ahem) the EU MDR [...]
Understanding Global Regulatory Authorities in the Medical Device Industry
You know what is common in all countries? No [...]
PMCF for IVDR and MDR – A Case Study and How-To
By now, most of us have struggled through at [...]