Instructor

Emily Malmberg

Emily Malmberg is employed at GBA Key2Compliance where she works as a consultant in Clinical Development. She has more than 18 years’ experience from life science research with a PhD in Biomedicine from Gothenburg University, Sweden / Mayo Clinic, Scottsdale AZ, USA, and a MSc in Biomedicine from Lund University, Sweden. In addition, she has been employed as a scientist at the Biotech Research and Innovation Centre (BRIC) at Copenhagen University in Denmark.

Emily also has experience from the IVD industry, where she worked as a Clinical Affairs Specialist with the main responsibility to collect and document performance data to demonstrate compliance with the IVDR. Her competence areas are research methodology, clinical and performance evaluation, clinical investigation, medical writing, literature review and project management.

Related courses to Emily Malmberg

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

IVDR Performance Evaluation, Risk Management, incl Post-Market Surveillance and PMPF

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
Dec 9
Online
CE-marking, IVDR, Post market, Risk

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