Combination Products

Standalone Module - Spring 2026 - 3 ETCS - CHF 3'150

  

Combination products include a combination of a medical device, and a drug (and/or biologic – only US). This module aims to provide participants with knowledge of the regulatory requirements for each component of a combination product including their similarities and differences. It will additionally provide participants with an understanding of combination product market launch considerations.  

Learning objectives

  • You understand the definitions in the EU and the US and familiarizes with the regulatory frameworks,
  • You understand regulatory requirements for each component of a combination product including their similarities and differences,
  • You understand use cases of combination products (e.g. diagnostic or therapeutic),
  • You understand the types and use cases of Combination Products,
  • You understand important standards and guidelines,
  • You know how to categorize and distinguish different medical device software (e.g. standalone, embedded, accessory, etc.) familiar with new regulatory developments (e.g., AI Act EU),
  • You are sensitized to moral and ethical issues (algorithm bias, representative data, hallucination, etc.),
  • You know how to apply transition timelines in EU,
  • You know how to structure technical documentation (eCTD vs. MDR Annex II, STED, ToC, etc.)

Scope & duration

3 ECTS points
This is equivalent to roughly 75-90 working hours

Start

The module takes place in spring term each year.
On-site (in-person) events for the upcoming spring term: 

  • 30.04.2026 (9-4pm) - Kickoff 
  • 10.06.2026 (9-4pm) - Wrap up and industry case study

📍On-site events take place at sitem-insel in Bern, Switzerland.

In between those onsite events you will have weekly assignments, such as reading, writing, presentation or short online webinars.
These dates might be subject to change. Please feel free to contact the School if you have any more detailed questions.

Fee

This module can be attended as single course at a fee of CHF 3'150.-
👉 Contact the School if you are interested in this module as a single course.

Founder, Chairman and CEO of confinis AG (Switzerland and USA)

Beat U. Steffen

Beat Steffen, RAC, FRAPS, Founder, Chairman & CEO of confinis AG, (Switzerland and USA) holds a MSc in electrical engineering an executive MBA and has 25+ years of experience in medical device and combination product development/manufacturing/quality management/regulatory affairs. He founded confinis ag in 2005 and co-founded Medical Human Factors AG in 2016, a company specialized in evaluating the use-related safety, effectiveness and usability of medical products.

Global Head Regulatory Medical Devices, Combination Products & Precision Medicine at Novartis

Mike Wallenstein

Mike Wallenstein Global Head Regulatory Medical Devices, Combination Products & Precision Medicine at Novartis has more than 25 years of experience in various aspects of the MedTech industry.