Is MDR Compliance Expensive?
The short answer is, yes, it can be. MDR compliance may not have been [...]
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 [...]
12 EU MDR Guidance Documents You Need
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, [...]
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 [...]
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 [...]
Performing Effective Literature Search – For EU MDR and Other Regions
For any medical device, there must be sufficient clinical evidence to corroborate compliance with [...]
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 [...]