Technical Documentation for IVDs (CE Marked under the European Regulation)

On-demand Training Course

Technical Documentation for IVDs (CE Marked under the European Regulation)

等級其他期間 4 hours

可報名: 線上隨選課程 Book your place

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.

On-demand - training that’s even more flexible

If you need to understand the requirements of this management system standard and are confident enough not to need tutor-led training, this online, self-paced course offers you complete flexibility.

You can study in your own time when it suits you, and you can access the course from any internet-enabled device 24/7.

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

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
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.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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