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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EU Clinical Trial Regulation: What you Need to Know
For manufacturers, clinical trials or at least the protocol [...]
The Post-Market Surveillance Document: Which Ones Do you Need?
It's not enough to make a device and put [...]
Meddev 2.7 1 Rev 4: Guidelines for Literature Search
MEDDEV 2.7.1 Rev. 4 remains the most important technical [...]
ISO Standards for Medical Devices: What they are and When you Need Them
The whole point of medical devices is to improve [...]
Self-Certification for CE Mark – An Overview
The gradual implementation of the European Medical Device Regulation [...]
Medical Device Reporting (MDR): How to Report Problems to the FDA
Even though every medical device manufacturer does their utmost [...]