Establishing State-of-the-Art & Clinical Data
For recertification under MDR, the 2016 guideline commands a thorough Clinical Evaluation of your medical devices. As daunting as it seems, the clinical evaluation is also the perfect opportunity to look at the entirety of the clinical data supporting your devices.
An important part of demonstrating that your device fulfills the three Essential Requirements defined by the MEDDEV 2.7/1 rev. 4 guideline is crafting a sound and objective state-of-the-art evaluation, and a thorough analysis of the clinical literature relevant to your device’s safety and performance.
Download the Whitepaper today to find out how you can better set up State-of-the-Art & Clinical Data for your organization.