MSE Master of Science in Engineering

The Swiss engineering master's degree


Jedes Modul umfasst 3 ECTS. Sie wählen insgesamt 10 Module/30 ECTS in den folgenden Modulkategorien:

  • ​​​​12-15 ECTS in Technisch-wissenschaftlichen Modulen (TSM)
    TSM-Module vermitteln Ihnen profilspezifische Fachkompetenz und ergänzen die dezentralen Vertiefungsmodule.
  • 9-12 ECTS in Erweiterten theoretischen Grundlagen (FTP)
    FTP-Module behandeln theoretische Grundlagen wie die höhere Mathematik, Physik, Informationstheorie, Chemie usw. Sie erweitern Ihre abstrakte, wissenschaftliche Tiefe und tragen dazu bei, den für die Innovation wichtigen Bogen zwischen Abstraktion und Anwendung spannen zu können.
  • 6-9 ECTS in Kontextmodulen (CM)
    CM-Module vermitteln Ihnen Zusatzkompetenzen aus Bereichen wie Technologiemanagement, Betriebswirtschaft, Kommunikation, Projektmanagement, Patentrecht, Vertragsrecht usw.

In der Modulbeschreibung (siehe: Herunterladen der vollständigen Modulbeschreibung) finden Sie die kompletten Sprachangaben je Modul, unterteilt in die folgenden Kategorien:

  • Unterricht
  • Dokumentation
  • Prüfung
Medical Device Market Access (TSM_MedDMA)

The course provides an in-depth overview on all relevant aspects for successfully introducing a medical device into the market. It will make use of the Stanford biodesign principle to evaluate the clinical need and concept development with respect to regulation and the specific medical device market restrictions. The corresponding topics include the important tasks during the development of a medical device (prior market access) as well as after its placement on the market.

Eintrittskompetenzen

This course requires knowledge about

  • technical design methods
  • mathematical statistics/data analysis
  • basic knowledge about standardization

Lernziele

The aim of this lecture is to

 

 

 

 

 

 

  • Know the important medical device design principle
  • Know all relevant aspects for the development of a medical device
  • Know and apply the Stanford biodesign principle to design and develop a commercially successful medical device
  • Understand the regulatory aspects within EU (MDR) and US (FDA)
  • Know the current standards used for designing and developing medical devices according to MDR
  • Understand the relevant aspects of the health system and business aspects within medical device market sector

Modulkategorie

Stage 1: Defining the clinical need

 

 

  • From bench to bed side. Understand the clinical need and make use of knowledge about disease fundamentals and observation/clinical problem identification.
  • Understanding the scientific language of medicine, the research culture as well as the ethical aspects in the context of medical devices.
  • Introduction into the medical device regulation

 

 

Stage 2: Screening and concept development

 

 

  • Knowledge of the classification of medical devices and the corresponding regulatory pathway within EU-MDR and US-FDA
  • Prototyping, concept screening and generating a MVP.
  • Overview on the legal requirements on the design and construction of medical products. This includes the requirement management as well as the verification and validation of development results.
  • Insights into the quality management system EN ISO 13485:2016 including testing, verification, and validation principles.

 

 

 

 

 

Stage 3: Product concept and business strategy

 

 

  • Understanding the basics in the usability according EN 62366, validation of the usability
  • Understanding the risk management according to ISO 14971 and having insights into the risk analysis.
  • Understanding biological safety according to ISO 10993 and some technical safety aspects (ISO 60601)
  • Knowledge of the CE-labelling in Europe and registration procedure in the USA. Product labelling (ISO 15233) and UDI.
  • Knowledge in current health systems and developing a reimbursement strategy.
  • Introduction into the clinical testing of medical devices and basic knowledge of "good clinical practice".

 

 

 

 

 

 


Lehr- und Lernmethoden

Theoretical

lectures combined with group-work

Bibliografie

 

  • Medical device design: Innovation from concept to market, Peter Ogrodik, Academic Press (2020). ISBN 978-0-12-814962-1
  • Biodesign – The Process of Innovating Medical Technologies, Paul Yock, Stefanos Zenios, Josh Makower, Todd Brinton, Uday Kumar, Cambridge Academic (2015). ISBN 978-1-107-08735-4
  • EU-MDR, US-FDA
  • Various standards

 

 

 

Vollständige Modulbeschreibung herunterladen

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