Performing Effective Literature Search – For EU MDR and Other Regions
For any medical device, there must be sufficient clinical evidence to corroborate compliance with [...]
Post Market Surveillance Under the EU MDR
There are only a handful of explicit things that you MUST do for Post Market [...]
Breaking Down EU MDR Implementation for Class 1 Medical Devices
Breaking Down EU MDR Implementation for Class 1 Medical Devices Breaking Down EU [...]
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, [...]
Literature Reviews for EU MDR
Want to know what the most commonly criticized document in an MDR submission is? [...]
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 [...]
Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to [...]
12 EU MDR Guidance Documents You Need
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but [...]
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 [...]
Term Refinement in Literature Search
A literature search is a systematic search through existing data in an organized way to [...]
