Is MDR Compliance Expensive?
The short answer is, yes, it can be. MDR compliance may not have been expensive in the past, but as the regulations…
20 Nov 2025
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
12 EU MDR Guidance Documents You Need
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With…
20 Nov 2025
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
Literature Reviews for EU MDR: Practical Tips
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
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
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
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A literature search for EU MDR is the systematic, documented search of published and unpublished sources for clinical data on your device,…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