EU MDR

The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019…

A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the…

Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is…

Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class…

The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout…

For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One…