FUSE-AI gains renowned regulatory expert as investor and advisory board member
Klaus-Dieter Ziel
Hamburg, November 3, 2025 – The Hamburg-based AI startup FUSE-AI announces the addition of Klaus-Dieter Ziel as a new investor and advisory board member. With more than 30 years of experience in regulatory affairs and medical device approval, Ziel brings unique expertise to the company and will play a key role in supporting FUSE-AI’s internationalization strategy.
Ziel was the founder and long-standing managing director of MEDCERT GmbH, a Europe-wide recognized Notified Body for CE certification of medical devices, which he successfully built up since 1994. In 2022, the company was acquired by DNV, a global leader in certification, testing, and risk management services.
As the Second Chairman of RAPS Germany e.V., part of the Regulatory Affairs Professionals Society (RAPS) – the world’s largest professional community for regulatory affairs with more than 30,000 members across over 100 countries – Ziel is highly connected both nationally and internationally.
His expertise includes, in particular, the EU MDR and ISO 13485 standards, including clinical evaluation as well as the regulatory frameworks for digital diagnostics and AI-driven solutions. This provides FUSE-AI with crucial added value in terms of approval processes, quality management, and market access in Europe and beyond.
“We are extremely pleased to have gained one of the most distinguished experts in the regulatory field of medical technology. His expertise and experience will help us scale our products internationally faster while maintaining the highest standards of quality and safety,”
says Matthias Steffen, CEO of FUSE-AI.
As a member of FUSE-AI’s advisory board, Ziel will support the company in addressing strategic issues related to regulatory frameworks for medical software.
“Artificial intelligence in medicine holds enormous potential but requires a solid regulatory foundation. I am delighted to contribute my experience and support FUSE-AI in becoming an international leader in this field,”
says Klaus-Dieter Ziel.
With Ziel’s addition, FUSE-AI not only strengthens its regulatory expertise but also gains a strategic partner for its expansion into international markets.