Who am I?

In my journey as a quality manager, I explored the details of IVD (In Vitro Diagnostic) medical device regulations and saw firsthand the challenges companies face in meeting complex compliance requirements. My experiences included managing technical documents for specific tests and working on certification processes, all of which improved my skills in setting up organized methods to ensure regulatory compliance.
During my time at various companies, I encountered confusion within teams about IVD CE certification requirements. Seeing the need for clarity and alignment, I led the creation of structured procedures that were widely accepted and produced real results. This success became the foundation for my mission to simplify CE marking procedures, helping companies to operate with confidence and independence within the IVD field.

What sets me apart? 

My mission is twofold: to make CE marking procedures easy to understand and follow, and to help clients handle regulatory complexities on their own. By offering consulting and practical support, I aim to give companies the knowledge and tools they need to improve their processes and ensure they meet all necessary regulations.