This one day course is designed to support manufacturers by confirming the information necessary to demonstrate clinical safety and performance of their product in accordance with the requirements of the European Medical Devices Directive. 

On completion of training, manufacturers will be able to determine if a clinical trial is required, prepare a clinical evaluation report including literature review and determine requirements for post-market clinical follow-up and post-market surveillance to support continuing compliance. 

How will I benefit?

  • Avoid frequent pitfalls of clinical regulatory submissions
  • Provide robust documentation in support of the clinical safety and performance of your device 
  • Ensure continuing compliance throughout device lifecycle. 
Become your company's leader on Clinical Evaluations today