This 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.
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
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
What is included?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Prior knowledge and learning
You should have a basic understanding of European IVD device regulations.
