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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Classifying Software as Medical Device in EU MDR
Introduction to Software as a Medical Device in MDR [...]
CER Medical Writer Qualifications for EU MDR: 7 Essential Skills
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 [...]
IVDR: State-of-the-Art for In Vitro Diagnostic Medical Devices
With the updates to the European Medical Device and [...]