Instructor

Susanne Grimsby

Susanne is one of our senior consultants, dedicated to supporting medical device and in vitro diagnostic (IVD) companies through a wide range of projects and training programs. She has a solid background from research and the life science business and with over 10 years of hands-on experience in QA/RA along, she brings a unique blend of technical expertise and practical insight to every project.

Throughout her career, she has collaborated closely with product development teams, implemented robust quality management systems, and guided products through the CE-marking process.

Susanne’s deep understanding of regulatory requirements and her practical experience in interpreting and applying them makes her an appreciated trainer. She is passionate about sharing her knowledge in our courses helping others to understand the “why” behind the regulations, giving them confidence to succeed.

Related courses to Susanne Grimsby

IVDR training series: Mastering IVDR Compliance

Training series contains 3 parts, half a day each.
  1. Intro to IVDR -Fundamentals of the IVDR and CE-marking of IVDs
  2. CE-marking - Risk classification of IVDs and Technical Documentation
  3. IVDR Performance Evaluation, Risk Management, PMS and PMPF
- Feb 5, 2026
Online
CE-marking, IVD, IVDR, Post market, Risk

CE-marking – Risk classification of IVDs & Technical Documentation

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
Online
CE-marking, Documentation, IVD, IVDR, Risk

Introduction to IVDR – Fundamentals of IVDR and CE-marking of IVDs

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

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