Provide evidence on safety, performance and benefit for your IVD device

The IVDR requires manufacturers to conduct and regularly update a performance evaluation of their IVD product to receive and maintain CE marking. With a structured and concise performance evaluation, you can provide evidence of scientific validity and analytical and clinical performance that demonstrates the benefit, safety and clinical utility of your IVD product.

Do you already know which aspects should be considered in your performance study? We also support you in planning, design and execution of performance studies and provide extensive training by our subject matter experts.

Need assistance with your performance evaluation

Take advantage of our services:

  • Creation and update of plans and reports for performance evaluation according to IVDR
  • Evaluation of performance data to meet regulatory demands
  • Conduct of in-depth literature reviews to gather scientific, analytical and clinical evidence
  • Gap analyses of your performance data
  • Evaluation of your marketing claims
  • Research for clinical experience data
  • Benefit-risk analysis
  • Development, planning and design of performance studies (including selecting study sites and creating case report forms)
  • Preparation and review of performance study documents (e.g. study plan, investigator brochure, patient information and consent)
  • Conduct and completion of performance studies (including data management, monitoring, statistical evaluation and final reporting)
  • Trainings and workshops on clinical affairs and performance studies

Please contact us if you want more Information or a non-binding offer on our IVD device services.