BSI's 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.

Benefits to Your Business

• 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.

Learning Objectives

On completion of this training, participants will be able to:

• 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.

Intended Audience

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

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.