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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Are You Over-Committing on Your EU MDR Post-Market Surveillance Plan?
All MedTech companies face increased post-market surveillance (PMS) requirements [...]
Classifying Software as Medical Device in EU MDR
Introduction to Software as a Medical Device in MDR [...]
7 Qualities of a Fantastic Medical Writer
Medical writers make up much of the medical device [...]
Five Practical Tips for Writing a Compliant Clinical Evaluation Report (CER)
Even for experienced medical writers and regulatory staff, writing [...]
EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions
The regulatory landscape in Europe is changing. In 2021, [...]
Analyzing the Differences between CERs for MDR versus MDD
Implementing the MDR or Medical Device Regulation will bring [...]