References – Lectures, Training Courses, Coaching

Here is a selection of our lectures, training courses and coaching services.

METEAN – Lectures, Training Courses, Coaching

2nd Hands-on Course on “Diagnostic and Interventional Endoscopy“ for Engineers and Medical Technicians

For the second time, the Medical Test and Demonstration Center METEAN at the Fraunhofer IIS is jointly running a hands-on course on “Diagnostic and Interventional Endoscopy“ for engineers and medical technicians with the Department for Internal Medicine II at the Waldkrankenhaus St. Marien Hospital and the German Society for Biomedical Engineering (DGBMT) within the Association of German Engineers (VDE) to promote a better understanding of endoscopic devices and work processes and methods.

Certificate of Advanced Studies in Medical Device Law at the University of Erlangen-Nürnberg

For several years, METEAN has been responsible for teaching the topic “Usability for medical devices“ in the seminars forming part of the Certificate of Advanced Studies in Medical Device Law. One of the topics of this seminar is the contents of DIN EN 62366 medical devices – application of usability engineering to medical devices. Furthermore, the course “Introduction into medical device law“ has been taught several times by METEAN lecturers.

Regulatory Affairs Expert in the MedTech Business Design Bootcamp

The aim of the annual MedTech Business Design Bootcamp is for groups to develop an idea for a project in the field of medical engineering and to obtain feedback from experts, entrepreneurs, and investors. Since September 2014, METEAN experts have been covering annual coaching in regulatory affairs and giving an insight into medical device law.

Lectures Given by our Speakers

  • “Research and regulated markets – How does this work together?“ – cross-cluster event by BioM on digitalization in medicine and healthcare, Christian Sauter, 11/24/2015, Martinsried
  • “Supplier risk management“ – MedConf lecture, Christian Sauter, 10/15/2015, Munich
  • “Risk management in research projects“ – DGBMT lecture, Christian Sauter, 09/18/2015, Lübeck
  • “Product development by a partner – Who holds the intellectual property rights?“ – lecture at the Symposium “PLM – OEM – ODM in the medical devices industry“, Christian Sauter, TÜV Rheinland Akademie GmbH, 04/01/2014, Nürnberg

METEAN Seminar Series

Many seminars and workshops that focused on the topics below have already been carried out in the METEAN premises:

  • Quality management for beginners
  • Introduction into medical device law
  • Quality management for people transferring from other fields
  • Technical documentation for medical devices
  • Risk management pursuant to ISO 14971
  • Regulatory software requirements – an overview for medical and pharmaceutical engineering
  • Usability for medical devices – normative provisions and implementation in practice
  • Usability for medical devices – a methodological guideline
  • Project management for manufacturers of medical devices
  • Clinical assessment
  • Ways of meeting the costs of your medical device
  • Statistical planning, conduct, and analysis of medical studies
  • StrategicPlay® for medical engineering – developing ideas and concepts with LEGO®
  • "Continua Health Alliance" – concepts, activities and practice
  • Continua in Europe – the certification method for medical devices