Caroline Aernouts
Senior Consultant RA MD
3+ years at QbD Group, expertise in Medical Device Software (MDSW)
Caroline specializes in Medical Device Software (MDSW) regulations and has been instrumental in helping clients navigate the complexities of IEC 62304 compliance and software lifecycle management. Her practical approach helps manufacturers implement robust eIFU solutions.
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eIFU Compliance Starts with Validation
Learn why system validation is the foundation of eIFU compliance and how to ensure your electronic Instructions for Use platform meets regulatory requirements under EU MDR and IVDR.
eIFU Versus Paper-Based IFU: What Are the Benefits of Going Digital?
Why do more and more manufacturers choose to move to eIFU? Learn about the range of benefits of replacing paper-based manuals with electronic instructions.
The 6 Crucial Advantages of Software as a Service for eIFU
SaaS has taken software development by storm. Learn about the six key advantages of delivering eIFU as Software as a Service.
A Guide to the eIFU Transition
Administrative and logistical hurdles around the switch from paper to eIFU can be daunting. This guide introduces the most important steps for manufacturers.
The Added Value of IFUcare's Multilingual Freephone Service to Their eIFU Solution
IFUcare provides a free telephone service so clients can request paper copies of IFU at any time, in any language. Learn about this unique service.