Technical Documentation for In Vitro Diagnostic Devices (IVDs)

This one-day intensive course enables greater understanding of the key requirements for technical documentation for IVDs, in line with the European IVD Regulation (IVDR) requirements in Europe.

A required part of conformity assessment and CE Marking is the need for Technical Documentation which includes the collation of supporting information about your IVD Device. Technical documentation is maintained throughout the product lifecycle. Learn how to assemble this and other types of required information so you can CE Mark your device in Europe.

Who should attend?

QA/Regulatory personnel involved in compiling technical documentation and design dossiers. Product design personnel and those in Research & Development for IVDs intended for the European market.

What will I learn?

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

  • Gain confidence in the requirements for technical documentation under the European IVD Regulation
  • Review and create documentation to support IVD products
  • Grasp how standards and guidance can be used to improve your technical documentation
  • Know what is expected by Notified Bodies for technical documentation during reviews and be better prepared
  • Avoid incomplete technical documentation which can result in unexpected delays or prevent market entry
  • Recognize the documentation requirements during the product lifecycle and the post market updates needed

How will I benefit?

This course will help you learn:

  • Technical documentation requirements under the European IVD Regulation
  • Be able to review technical files and be able to create new files to support IVD products
  • How standards and guidance can be used to improve technical documentation
  • Expectations of Notified Bodies for technical file content during reviews, both at launch and during the product lifecycle

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.