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
  • Lunch and refreshments
  • Certificate

 

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >

Course Guide

Download the course flyer.


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. In the event of a classroom-based course being deemed unsafe, your training booking will be automatically transferred to online delivery using our highly-interactive virtual classroom - Connected Learning Live.

If you have any questions regarding your booking, please contact training@bsigroup.com or call +44 345 086 9000.


Booking a course delivered via Connected Learning Live?

Take advantage of our exclusive offers, only available in July and August 2020*

Book a July or August Connected Learning Live course date and you’re entitled to unlock one of the following benefits:

  • Option 1: Get 50% off a second delegate booking fee
    Offer applicable to public courses delivered via Connected Learning Live in July and August 2020 only. Second delegate must attend the same course date
  • Option 2: Save £500 on a BSI Diploma in Quality Management
    Offer applicable to delegates that have booked a public course delivered via Connected Learning Live in July and August 2020 only

Contact our training team today to find out more and book your place. Call +44 345 086 9000 or email training@bsigroup.com

*Terms and conditions: Applies to all public BSI UK training courses, taking place in July and August 2020 via Connected Learning Live only. Call our training team on +44 345 086 9000 or email training@bsigroup.com for more information. Second delegate must attend the same course date as the first delegate. Moves, changes and cancellations are not permitted. Payment required or invoice issued at the time of bookings. This offer does not apply to BSI re-sellers or Cybersecurity and BRCGS courses. Offer is for new BSI UK training bookings only. Offer is not to be used in conjunction with any other offer. Offer subject to availability of training courses. Bookings are non-transferable. All other terms and conditions for training courses apply.