CAS ETH in Regulatory Thinking

Tomorrow’s health innovations won’t fail because of lack of brilliance —they’ll fail because they didn’t meet the right expectations at the right time.
From digital therapeutics and AI diagnostics to connected implants and
lab-on-chip systems, every breakthrough now shares a common reality: if it’s not regulatory-ready, it’s not market-ready.

The CAS in Regulatory Thinking – Applied HealthTech (ETH Zurich) doesn’t teach regulation as compliance theory. It trains you to think like a strategist — across the patient journey, the payer’s threshold, the clinical unmet need, and the regulator’s lens.

This is where compliance meets business success.

Designed for founders, scientists, and healthtech professionals, the program is structured around five advanced microcredentials that reflect real-world regulatory tipping points — the places where startups pivot, investors hesitate, and innovations either launch or stall.

What makes this course different?

Simulations, not slides: You don’t just read standards. You defend design files, run mock audits, and pitch regulatory strategies to real-world stakeholders.

Cross-stakeholder fluency: You’ll practice framing your product for payers, patients, clinicians, and competent authorities — in one language.

Outcomes you can show: Deliverables include performance plans, CE
strategies, SaMD submissions, and AI audit frameworks — all built around
your own product ideas.

Your result?

A portfolio of regulatory strategy that speaks to investors, withstands audits, and accelerates market entry — plus a Certificate of Advanced Studies (CAS) or ETH-endorsed microcredentials to prove it.

In a market where knowing regulation is knowing your business — this is the edge.

Participants of the MAS ETH in digital Clinical Research programme can choose this CAS ETH in Regulatory Thinking as their third CAS programme or book it separately.

Get in touch and book your personal consultation on the MAS ETH in digital Clinical Research: