Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed…
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
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
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
Post-Market Surveillance Under EU MDR: The Complete Guide
Post-market surveillance (PMS) under EU MDR is the system every manufacturer must run to proactively collect and review real-world data on its…
20 Nov 2025
Performing Effective Literature Search – For EU MDR and Other Regions
A literature search for EU MDR is the systematic, documented search of published and unpublished sources for clinical data on your device,…
20 Nov 2025
Systematic Literature Review Course – Onboarding: Welcome!
Welcome to the Systematic Literature Review Course! We’re thrilled to have you on board. Especially in this industry, time is precious, so…
20 Nov 2025