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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Literature Search Protocol for EU MDR: When and How to Update Your Review
Getting the long-awaited CE mark is certainly something to [...]
Switzerland’s Medical Device Regulation and the EU Regulations
The medical device industry is thriving globally. Not only [...]
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
In July 2021, Regulation (EU) 2019/1020 on market surveillance [...]
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 [...]