Clinical Evaluation for Medical Devices

The course is designed to provide you with an understanding of the clinical evaluation process including details on the regulatory requirements, the principles of clinical evaluation, how they are performed and documented. 

Practical activities throughout the day provide the opportunity to apply your skills in order to perform a clinical evaluation within your organization upon completion of the course.   

How will I benefit?

This course will help you to:

  • Identify the requirements of clinical evaluation against the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents
  • Determine when clinical evaluation is undertaken and the frequency of updates
  • Interpret and communicate the key requirements and expectations of medical device clinical evaluation to your organization
  • Apply the clinical evaluation process for medical devices within your organization