Instructor

Susanne Grimsby

Susanne Grimsby is employed at GBA Key2Compliance as a senior consultant in the Regulatory Affairs team. Susanne has more than 30 years of experience from the Life Science business of which the last 8 years in the medical device industry. Susanne has holds positions as QA/RA Manager and QA/RA consultant and has also acting in roles as PRRC, project manager and trainer for IVDR courses. Her experience is mainly from small and mid-size medical device and IVD companies where she has served the companies in various QA/RA activities to ensure quality management and regulatory compliance.

Susanne is an appreciated trainer and has very good knowledge of IVDR, the new  EU Regulation for IVD devices, which she is happy to share.

Related courses to Susanne Grimsby

IVDR training series

Training series contains 3 parts, half a day each.
  1. Fundamentals of the IVDR and CE-marking of IVDs
  2. IVDR – key elements of the risk classification and technical documentation for the CE-marking process.
  3. IVDR Compliance: Demonstrating Performance and Safety for IVD Devices
Nov 18
- Dec 9, 2025
Online
IVD, IVDR

Technical Documentation and risk classification, according to IVDR (746/2017)

Learn about the new rule-based risk classification. Understand how the risk classification impacts on the conformity assessment route Learn about the general safety and performance requirements and how to demonstrate compliance Understand the structure and content of the Technical Documentation Understand how design changes to the product design impact on the technical documentation
Nov 27
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CE-marking, Documentation, IVD, IVDR, Risk

Introduction to IVDR (746/2017) and CE-marking of In-Vitro Diagnostic devices

Learn about the IVDR and CE-marking of IVD medical devices. Understand the regulatory requirements for IVD medical devices. Understand the obligations under IVDR
Nov 18
Online
IVD, IVDR, Regulatory Compliance

The IVDR challenges – do you have everything under control?

Online
IVD

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