Kirsten Van Garsse
Dir. Authorised Representative Services & Manager IVD
20 years of experience in the IVD field
With 20 years of experience in In Vitro Diagnostics, Kirsten leads our IVD regulatory services and Authorised Representative offerings. She has deep expertise in IVDR compliance and helps IVD manufacturers successfully transition to electronic instructions for use.
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MedTech Europe Pushes for Wider Adoption of eIFU – Now Across Both Lay-Use Devices and Near-Patient Tests
MedTech Europe has taken another significant step in its push for digital healthcare, publishing new guidance on eIFU for near-patient tests following its position paper on lay-use devices.
New IVDR/MDR Overview of Language Requirements for Manufacturers of Medical Devices
The European Commission published an overview of language requirements for medical device manufacturers. Learn what this means for eIFU.
The Power of eIFU in a Product Recall Process
Product recalls are a fact of life for Medical Device manufacturers. Learn how eIFU is helping to ease the pain and make recalls more efficient.
e-IFU Requirements Translated for Implantable Medical Devices
After the European Commission published Regulation 2021/2226, manufacturers of implantable devices face new eIFU requirements. Learn what is expected.
How to Ensure the Safety and Security of an eIFU Website
Any data managed online must be protected, and eIFU systems are no exception. Learn what manufacturers should keep in mind for safety and security.
The Switch to eIFU: Understanding the Change Process
Making the change from paper IFU to online eIFU can lead to huge efficiency gains, but it must be done right. Learn about the change process.