Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs)

To provide an understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for clinical evidence.

If you are involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe, this intensive one day course will enable a greater understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for clinical evidence.

Who should attend?

QA/Regulatory and R and D scientists involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe.

What will I learn?

Upon completion of this training, delegates will be able to:

  • Appreciate the need for performance evaluation and how it fits into product development under the European IVD Regulation (EU 2017/746)
  • Learn key definitions of performance evaluation and clinical evidence under the IVD Regulation
  • Gain awareness of the scope of the European regulatory requirements for IVD clinical performance studies under the IVD Regulation
  • Distinguish between non invasive and interventional clinical studies and understand requirements for vulnerable and protected study subjects
  • Apply practical considerations for study design and protocols
  • Plan and document clinical evidence under the IVD Regulation; with an appreciation of how this information should be maintained throughout the product lifecycle

How will I benefit?

This course will help you:

  • Learn what an In Vitro Diagnostic is and what is required to demonstrate performance according to the IVD Regulation
  • Appreciate what the design and development stages are during IVD product development
  • Understand the definitions of performance evaluation that incorporate clinical evidence under the In Vitro Diagnostic Regulation
  • Identify the analytical performance studies required
  • Explore clinical performance studies including the legal and regulatory requirements and practical considerations
  • Document clinical evidence and maintain the documentation throughout the life cycle of the product

What is included?

  • You will gain 8 CPD points on completing the course
  • You will be awarded an internationally recognized BSI Training Academy certificate
  • Training course notes
  • Certificate

 


Classroom-based training: Ready when you are

When you’re ready for face-to-face training again, we’re ready to welcome you.

As we all adjust to greater freedom around travel and meetings, we want to reassure you that our training team has worked with venues and tutors to enhance measures to keep you safe. Our carefully selected training venues continue to operate social distancing procedures, with readily available sanitizer stations at high-touch points throughout the venue. Rigorous deep cleaning procedures continue, providing you with peace of mind during your time at the venue.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.