Continuing Education
Regulatory thinking becomes a catalyst for innovation, market access and entrepreneurial excellence. It will serve as a springboard for strategists who want to play an active role in shaping the modern medical products of tomorrow. It teaches the basics and deepens them with cutting-edge innovation topics (artificial intelligence, digital therapeutics, companion diagnostics, new in-vitro diagnostics etc.).
CAS ETH in Regulatory Thinking
Turn regulatory and compliance into your competitive ad-vantage. Regulatory Thinking connects evidence, compliance and market logic from day one – for faster, market-ready innovation.
Programme Structure and Content
The CAS ETH in Regulatory Thinking can be described as a "studium generale" that will promote you to a generalist in the field of regulation and certification. You will get an overview in a rapidly changing healthtech market and be able to identify and guide different specialists. The programme gives insight in the various disciplines in regulatory affairs activities and compiles these in a unique approach, defined as "Regulatory Thinking". The main topics are:
The course consists of 5 modules with a specific topic each that can be combined into the CAS ETH in Regulatory Thinking. The programme translates regulatory requirements into robust decisions, evidence and operational logic and makes transfer visible through concrete working dossiers and a structured defence. In contrast to comparable, traditional courses, it does not focus on knowledge presentation only but embedded learning during regulatory case and strategy discussions.
Tuition language(s): English
Credits: 15 ECTS credits
The CAS ETH in Regulatory Thinking is recognized as an elective course of the MAS ETH in Digital Clinical Research
Module 1: Regulatory Compass & Evidence Foundations
Build your global regulatory compass for strategy, foresight, and market
access.
Module 2: Data, Diagnostics & Lifecycle Logic
Turn ideas into compliant, market-ready devices with integrated strategies.
Module 3: AI, Sandbox & Tool Governance
Master AI and new tools to manage your regulatory affairs.
Module 4: Software as a Medical Device & Digital Therapeutics Operations
Align agile software development with compliance, security, and
reimbursement.
Module 5: Integration & Defense Preparation
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.
You will
- understand different regulatory landscapes
- know how to set up design and development processes
- use and evaluate validation tools
- learn how to develop a clinical strategy
- know about different certification and reimbursement strategies.
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.
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.
Master’s degree acknowledged by ETH or equivalent educational
qualifications, plus professional experience relevant to the programme.
• Required language skills: English: C1 – external pageShow proficiency scales
• Language(s) of performance assessment: English
Start: January 2027
Duration: 6 months
Application period: 1.9. - 15.11.2026
Location: ETH Zurich and online
Programme fee: CHF 9'730
Administration fee:
CHF 50 for persons with a Swiss university degree,
CHF 150 for persons with another university degree
(non-refundable, credit card payment only)
Apply online here
CV, motivation letter and evidence of prior education and professional
experience required.
Questions about the application:
ETH Zurich, School for Continuing Education
HG E 17-18.5, Rämistrasse101, 8092 Zurich,
Tel. +41 44 632 56 59
Organiser
Professor Jörg Goldhahn
Programme Director
Dr. DietmarSchaffarczyk
Course Leader
Contact
ETH Zürich
D-HEST, Translational Science
Leopold-Ruzicka-Weg 4
8093
Zürich
