Shpetim is a quality and regulatory affairs specialist with more than six years of experience bringing AI-based software medical devices to market in Europe and the US. Before joining contextflow, he led Quality and Regulatory Affairs at IB Lab in Vienna. There he managed a portfolio of more than 15 certified SaMD products, achieved CE certification for over ten devices, and secured several FDA 510(k) clearances. His expertise covers MDR, ISO 13485, ISO 14971 and IEC 62304, along with risk management, cybersecurity, and post-market surveillance. Shpetim holds an MSc in Medical Engineering & eHealth from FH Technikum Wien, which he completed with distinction. He also has a BSc in Electrical and Electronic Engineering.

Favorite meal: Anything from Mediterranean cuisine, especially a good home-cooked meal made with plenty of high quality olive oil. Simple, fresh ingredients and good company are hard to beat.

Recommended reading: Free: Coming of Age at the End of History by Lea Ypi

People would be surprised to learn…that I grew up in Albania, studied and lived in Turkey, and eventually made Vienna my home. I’ve always enjoyed stepping outside my comfort zone, exploring different cultures, and trying to understand how people see the world differently.

If I wasn’t working as Head of Quality Management, I would be…building a company. I’ve always been fascinated by entrepreneurship, technology, and the challenge of turning an idea into something people genuinely need.

Most rewarding part of my job: Seeing the connection between the work we do behind the scenes and the impact a product can have in the real world