Clinical Evaluation according to MDR
The Clinical Evaluation (CE) is part of a complete technical documentation of medical devices and in vitro diagnostic medical devices and is essential for their approval and marketing. Manufacturers must prepare a comprehensive CE as part of the conformity assessment procedure according to MDR.
What you should consider and how to create the document? In the BAYOOSOFT Risk Manager blog post “Clinical evaluation: Seamless documentation according to MDR” you will learn interesting facts about this topic.
BAYOOSOFT Risk Manager: Our solution for Clinical Evaluation according to MDR
The BAYOOSOFT Risk Manager is our validated software solution with which we support you from risk management to regulatory and product requirements to usability and of course the CE according to MDR.
With the extension module for the CE, we enable you to generate documents that are compliant with the MDR and MEDDEV 2.7.1 rev4.
In addition, you can find out more about our MedTech solutions here.