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
  • 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 >


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.