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Ortzi OLASOLO

Medical Device and Combination Product Consultant
Beyond Conception GmbH
Basel, Basel-Stadt, Switzerland

Ortzi Olasolo is a seasoned Medical Device Consultant at Beyond Conception GmbH, based in Basel, Switzerland. With over four years in this role, he has developed a robust expertise in navigating complex regulatory frameworks and delivering tailored compliance solutions to international clients. His work includes providing strategic regulatory support in response to Notified Body requests, particularly regarding Article 117 and medical device conformity assessments. Ortzi has also successfully developed end-to-end, ISO 13485 compliant Quality Management Systems (QMS) for various clients, including the creation and review of Standard Operating Procedures (SOPs) and managing 21 CFR Part 4 remediation projects. e is also deeply involved in the development of Clinical Evaluation Plans, Post-Market Clinical Follow-up (PMCF) Plans, and associated reports. His role extends to delivering expert-led training and workshops on medical device regulations, ensuring that his clients are well-prepared to meet the evolving demands of the industry.

His educational background includes a Master’s in Biomedical Engineering from the Universidad de Navarra and a Bachelor’s in Bioengineering from the Universidad Politécnica de Madrid. Ortzi’s skills span across ISO 14971, FDA QSR, and other key regulatory standards, making him a valuable asset to any project that involves navigating the intricate regulatory landscape of medical devices and combination products.

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