Clinical evaluation for Medical devices

Our Clinical Evaluation for Medical Devices 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.

Prerequisites:

  • Familiarity with own device clinical safety and performance issues  
  • Awareness of:  

Essential Requirements (Annex I) and Clinical Evaluation (Annex X) of the European Medical Device Directive or Essential Requirements (Annex 1) and Clinical Evaluation (Annex 7) of the European Active Implantable Medical Device Directive  

MED DEV 2.7.1 or GHTF guidance document SG5/N2R8


Who should attend?

  • Medical Device R&D Engineers and Scientists  
  • Clinical and Regulatory Affairs Professionals

Learning objectives

  • Determine whether or not a clinical investigation is required for their device
  • Prepare a clinical evaluation in accordance with MED DEV 2.7.1 and GHTF Guidance Documents
  • Implement risk evaluation pre/post review
  • Establish design and intended use equivalence with competitor and pre existing designs
  • Identify data available from the clinical literature 
  • Supply and prepare documentation relating to clinical investigations that meets Notified Body requirements (if clinical investigation was deemed necessary and completed)
  • Demonstrate that there is sufficient clinical data to meet the safety and performance requirements of the device
  • Identify residual clinical risks and determine whether post-market clinical follow-up is required
  • Maintain and update clinical evaluation documentation throughout post-market product lifecycle

Course Benefits

  • 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. 

Next Steps

  • Lead Auditor: ISO 13485 training course - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
  • Medical Devices Risk Management: ISO 14971 training course - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.