The conformity assessment can be considered as the procedure through which compliance to the requirements of the MDR is demonstrated. The conformity assessment is the mandatory step that needs be

The version of 2016 of ISO 13485:2016 has a new requirement compared the previous version which is related to the so-called Medical Device File. The medical device file (MDF) is

Clinical evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and performance. The evaluation is based on a comprehensive analysis of

What are Common Specifications? The definition of common specifications according to the EU MDR and  IVDR is “ set of technical and/or clinical requirements, other than a standard, that provides

Introduction to MDR QMS Requirements A complete and comprehensive understanding of the EU MDR QMS requirements is becoming essential for an effective implementation of the New European Medical Device Regulations. We