This description is only available in English.

  • January 2027

    Start
  • 6 months

    Duration
  • ETH Zurich, online

    Location
  • English
    Tuition language
  • 01.09–15.11.2026

    Application period
  • CHF 9,730

    Programme fee

In brief: The CAS ETH in Regulatory Thinking

Turn regulatory and compliance into your competitive advantage. Regulatory thinking connects evidence, compliance and market logic from day one – for faster, market-ready innovation.

Structure and content

Programme description

The programme translates regulatory requirements into robust decisions,
evidence and operational logic and makes transfer visible through concrete
working dossiers and a structured defence.

Objectives

Participants learn to define scope and claims, design evidence pathways,
structure data and operational logic, implement AI governance in a traceable
way and defend decisions consistently in realistic stakeholder situations.

Professional perspectives

The CAS strengthens roles in regulatory affairs, QA, product, clinical translation, diagnostics, SaMD and AI health. Participants gain robust methods for audit readiness, less rework, stronger stakeholder dialogue and visible responsibility in interface projects.

Structure and format

Part-time hybrid programme lasting 6 months. Five modules with online input,
reading, group work and a three-day workshop. Each module produces a working dossier. All dossiers feed into an integrated final dossier with oral defence.

Additional information

Modules of 3 ECTS each:

  1. Regulatory compass & evidence foundations
  2. Data, diagnostics & lifecycle logic
  3. AI, sandbox & tool governance
  4. SaMD/DTx operations
  5. Integration & defense prep

The CAS will later be complemented by stackable microcredentials and connects
internal and external target groups through one shared methodological logic.

The CAS Regulatory Thinking is recognised as an elective course of the MAS Digital Clinical Research.

Tuition language(s)

English

Credits

15 ECTS credits

Attendance of individual courses

Selected modules are offered as microcredentials or individual continuing education courses.

Target group and admission

Target group

Professionals working at the interface of health, engineering, software and AI, from healthtech, medtech, diagnostics, SaMD, AI, regulatory, QA, product, engineering and clinical translation, as well as from ETH. 

Requirements

Master's degree acknowledged by ETH or  equivalent educational qualifications (Rector's directive on admission), plus professional experience relevant to the programme.

Required language skills

Language(s) of performance assessment

English

Dates and venue

Start

January 2027

Duration

6 months

Application period

01.09–15.11.2026 (rolling admission)

Location

ETH Zurich and online

Fees

Programme fee

CHF 9,730

Application fee

CHF 50 for persons with a Swiss university degree, CHF 150 for persons with another university degree (non-​refundable, credit card payment only)

Withdrawal fee

  • Within 30 days after the admission date: free of charge
  • More than 30 days after the admission date: CHF 4,865
  • After the start of the programme: CHF 9,730

Application

Questions about the application

ETH Zurich, School for Continuing Education, HG E 17–18.5, Rämistrasse 101, 8092 Zurich, Tel. external page +41 44 632 56 59, E-mail

Application documents

Additional application documents

  • CV
  • motivation letter

Organiser

Programme management

Professor Jörg Goldhahn
Programme Director
Professor Jörg Goldhahn
Dr Dietmar Schaffarczyk
Programme Manager
Portrait Dietmar Schaffarczyk

Contact

Professor Jörg Goldhahn
  • +41 44 633 20 69

ETH Zurich
D-HEST
Leopold-Ruzicka-Weg 4
8093 Zurich

Responsible body

ETH Zurich, D-​HEST
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