Summary

“EU MDR is the spiritual ancestor of the EU AI Act”.

In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes Kevin Schawinski, astrophysicist turned AI entrepreneur and CEO of Modulos AG. Kevin shares his journey from studying black holes to building AI governance solutions, and explains how the EU AI Act is modeled after the EU Medical Device Regulation (MDR). He highlights the parallels between product safety regimes in MedTech and emerging AI regulation, offering practical insights for organizations preparing for compliance.

The conversation explores ISO 42001 as a baseline AI management system standard, the implications of fine-tuning large models, and why medical device professionals may actually be better prepared than most industries to navigate AI regulation. Kevin emphasizes the importance of responsible deployment across culture, processes, and technology, and leaves listeners with a clear message: MedTech organizations already have the tools and mindset to take a leadership role in shaping trustworthy AI.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:10 Introducing Kevin Schawinski - From Black Holes to AI

03:29 How EU AI Act Parallels EU MDR

07:00 MedTech Readiness for AI Compliance

11:00 Defining and Building Responsible AI

20:13 Managing Risks Across Supply Chain

23:19 Announcements and Key Takeaways

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Suggested links:

LTR: Contrasting US and EU Approaches to AI Regulation.

LTR: Eight Practical Actions to Future-Proof Your AI Enabled Medical Devices.

ACHIEVE: PMS Workshop.

Key Takeaways

* The EU AI Act mirrors MDR’s risk-tiered framework.

* MedTech pros are better prepared than most for AI rules.

* ISO 42001 is the new baseline for AI management.

* 42001 helps, but doesn’t ensure AI Act compliance.

* Fine-tuning AI models shifts full responsibility to you.

* Responsible AI needs culture, process, and tech alignment.

* EU and U.S. AI laws are moving fast but differ in approach.

* U.S. states push ahead, driving calls for federal law.

* AI supply chains create hidden liability risks.

* MedTech can lead in trustworthy AI using existing practices.

Keywords

EU AI Act, MDR, Risk-tiering, ISO 42001, Compliance, Liability, Fine-tuning, Responsible AI, Trustworthy AI, Supply chain, MedTech, Governance

About Kevin Schawinski

Kevin Schawinski is the Co-Founder & CEO of Modulos AG, where he leads the development of AI governance solutions that align with global standards such as the EU AI Act and the U.S. NIST AI Risk Management Framework. An astrophysicist turned entrepreneur, he previously served as an assistant professor at ETH Zurich, published in leading journals like Nature and Science, and pioneered the use of machine learning in astrophysics. Today, Kevin contributes to international AI policy efforts with NIST and the European Commission, advocating for responsible and trustworthy AI innovation.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

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