Updates of the MDCG 2019 9 Rev 1, SSCP, and Others
The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019…
20 Nov 2025
How Literature Review Automation Improves Performance Evaluation Reports (PER) Program Management for the IVDR
A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the…
20 Nov 2025
Literature Reviews for EU MDR
Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is…
20 Nov 2025
Breaking Down EU MDR Implementation for Class 1 Medical Devices
Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class…
20 Nov 2025
Effectively Handling Corrective and Preventive Actions (CAPA) Process with EU MDR
The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout…
20 Nov 2025
Choosing the Best Systematic Literature Review Tools
CiteMed's own platform is the strongest fit for medical device and pharma regulatory submissions specifically, with DistillerSR as the enterprise alternative for…
20 Nov 2025
Common Notified Body Feedback on Literature Review (And How to Address Them)
Who This Was Written For? To celebrate the latest release of our systematic literature review tool , the CiteMed team wanted to…
20 Nov 2025
Performing Effective Literature Search – For EU MDR and Other Regions
For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One…
20 Nov 2025