Ortzi Olasolo is a regulatory expert with a solid background in biomedical engineering. He holds a MsC on Medical Devices from University of Navarra. He has been working as a consultant for Beyond Conception since 2021, supporting a variety of companies in several areas (Quality Management Systems, Risk Management, Technical File reviews, Notify Body Opinion submission process and Clinical Evaluations). Before starting to work as a consultant for Beyond Conception, he gained extensive experience in Quality Management Systems, Design Controls and Risk Management in the field of Pharmacy Compounding Devices as Development and Quality Engineer. He has authored several clinical evaluations for drug device combination products.