IVDR Common Errors: Navigating Notified Body Expectations

Explore the notified body process and IVDR technical documentation with experts Margot Borgel, Director of IVD Global Regulatory Affairs at RQM+, and Vincent Balgos, Director of Medical Device Solutions at Jama Software®.

You will gain a thorough understanding of these topics and more:

  • The notified body’s approach to technical reviews
  • Key considerations from the notified body’s perspective
  • Common mistakes made when compiling technical documentation