Course Aim

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.

Course Description

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

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

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.

How will I learn?

Our on-demand courses allow learners access to knowledge-based content in real time, anywhere, and at anytime. Using established learning and interactive digital technology, on-line attendees are guided through the course content, at their own pace, providing opportunity to review, test knowledge and confirm understanding, as they progress through the course.

What will I gain?

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

Modules

• Module 1: Background to the IVDR
• Module 2: Expectations of the IVDR and Compliant Technical Documentation
• Module 3: Sections 1 to 4 of Annex II of the IVD Regulation
• Module 4: Demonstrating Conformity and Section 5 of Annex II
• Module 5: Section 6 of Annex II Product Verification and Validation
• Module 6: Annex III Post Market Surveillance