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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In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges
All medical devices have their merit since all of [...]
Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?
Most regulatory staff can define post-market surveillance relatively succinctly. [...]
Medical Device Regulations – Links You Should Be Aware Of
Medical device regulations are no joke. It's pretty important [...]
Literature Search: How Much Research is Enough?
The research process is often thought of as a linear, [...]
The Top 5 Regulatory Requirements for the Medical Device Industry
Being in the regulatory industry is not as cut [...]
Vigilance Reporting Under the MDR: Insider’s Guide
Implementing the European Medical Devices Regulation (MDR; 2017/745) and [...]