From first idea to CE-marked device.
Independent engineering, quality management and regulatory support for medical devices. More than 30 years of experience.
Your engineering and consulting partner for medical devices.
I support your design, quality management, CE marking and regulatory affairs. You work with one engineer from the first question to the finished dossier, not with a project team that changes along the way.
More than 30 years of experience in the design and management of medical devices. In 1986 I founded Spiegelberg GmbH & Co. KG, the well known manufacturer of ICP monitors and antimicrobial CSF catheters.
Since 2013 I have been offering that knowledge wherever a project needs it. I also work as a Senior Scientist in The Interface Group at the Department of Physiology of the University of Zurich.
- Founded Spiegelberg GmbH & Co. KG in Hamburg in 1986 and led it until 2013
- Senior Scientist at the University of Zurich since 2019
- More than 60 published patents and patent applications
One partner for the whole development path.
I can take a device from the first technical idea to the first sale, or step in where your team needs support.
Concept and intellectual property
- Find the technical solution
- Prepare the patent application
Development and testing
- Design the feasibility model
- Run all tests and experiments
- Design the prototype
Documentation and approval
- Prepare the design dossier
- Prepare the technical documentation
Supply and market
- Find the supplier
- Find distributors
- Support the sale
Describe your project in two or three sentences and I will tell you where I can help.
Get in touchCompetences
All research and development activities for medical devices, from mechanical design to firmware and the technical file.
Regulatory and quality
- Technical documentation for CE marking
- Technical documentation for design examination
- Consultation procedure for devices containing silver
- Quality management systems
Mechanics and fluids
- Mechanical design
- Dimensioning
- SolidWorks
- Biofluid mechanics
Electronics and software
- Electronics
- Microprocessor systems
- Firmware and software
Curriculum vitae
- 1952
- Born in Hamburg.
- 1971-1979
- Studied mechanical engineering at the universities of Karlsruhe and Berlin.
- 1979-1986
- Research on the design of artificial hearts, Free University of Berlin.
- 1980
- Visiting fellow, University of California, San Francisco.
- 1981
- Visiting fellow, University of Utah, Salt Lake City.
- 1989
- Doctor of Engineering, Dr.-Ing.
- 1989-2013
- Owner, Managing Director and Chief Technology Officer of Spiegelberg GmbH & Co. KG, Hamburg. Design, production and sale of monitors and catheters for the brain.
- 1996-2012
- Quality Management Officer and Regulatory Affairs Officer, Spiegelberg GmbH & Co. KG.
- since 2013
- Consultant for medical devices. Engineering, research and development, QM systems and regulatory affairs.
- 2014-2019
- Academic Guest, The Interface Group, Department of Physiology, University of Zurich.
- since 2019
- Senior Scientist, The Interface Group, Department of Physiology, University of Zurich.
Awards
- 2004
- Innovation Award of the City of Hamburg, for the design of antimicrobial ventricular catheters.
- 2008
- Award for Innovative Medical Technology, German Federal Ministry of Education and Research, for a new method of non-invasive blood pressure measurement.
- 2009
- Award for Innovative Medical Technology, German Federal Ministry of Education and Research, for a catheter that prevents bacterial access by means of a balloon filling the catheter lumen.
Publications and patents
More than 20 peer-reviewed papers, 2 book chapters, more than 20 conference contributions and more than 60 published patents and patent applications, from 1979 to today.
See the full listTell me about your device.
Write a few sentences about where the project stands. You will hear back from me personally, in English or German.
info@spiegelberg.consulting
+41 79 826 27 24
Spiegelberg Consulting
Dr.-Ing. Andreas Spiegelberg
Bergstrasse 23, 8810 Horgen, Switzerland
Dr.-Ing. Andreas Spiegelberg
Bergstrasse 23, 8810 Horgen, Switzerland