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Stefan Schmidt holds a PhD in physics. He is active in the medical-device field since 1997 and an instrumental player in the development of Particle Therapy Systems.

In various key functions, he gatherd particular experience in medical-device development processes, the regulatory and quality-management environment, particle therapy techniques and components, the clinical environment in radiation therapy, and in project and product management under challenging conditions. He also gained deep insights in other advanced non-medical technologies.

Contact

Email:    info@schmidt-particles.com
Phone:   +49 2206 9403590
Mobile:  +49 177 2091008

Expertise

  • Medical Devices and Development Processes
    ISO 13485 • 21 CFR 820 • Medical Device Directive (MDD, 93/42/EEC) • Medical Device Regulation (MDR, regulation (EU) 217/745) • IEC 60601 series • CE marking and FDA approval processes • Risk Management (ISO 14971) • Requirements Management • Verification & Validation • Configuration Management • Quality Management • Change Management • Systems Engineering • System Architecture
  • Technical
    Radiation therapy and related techniques (dosimetry, imaging, patient positioning, control systems, treatment planning, ...) • particle accelerators • accelerator physics • beamline magnets • superconductors • cryogenics
  • General
    Project Management • Product Management • Team Management • R&D
  • Long-term, in-depth expertise in Particle Therapy

Projects

  • New proton therapy (PT) facility project in Tianjin (2018-2020)
    Company and team build-up support and PT system development activities for a new system vendor in PT as head of systems engineering an senior scientist (under permanent employment contract)
  • Introduction of improved PT system architecture (2017 - 2018)
    as Overall System Architect for a PT system vendor (under permanent employment contract)
  • Development of a new compact PT product line (2017 - 2018)
    as Overall Technical Lead for a PT system vendor (under permanent employment contract)
  • Particle therapy product and roadmap definition (2015 - 2017)
    Market monitoring, introduction of new product features, and research coordination as PT product manager (under permanent employment contract)
  • Tender process management (2014 - 2015)
    Involved in generation and presentation of several successful tender/RFP responses for a PT system vendor
  • Implementation of new risk management process (2014)
    Consulting services for updating existing RM process of a medical-device company acc. to new normative requirements (EN ISO 14971, IEC / EN 60601-1, 2nd and 3rd edition)
  • Development of a superconducting fault current limiter (2010 - 2013)
    Project management activities for a publicly funded multi-company development project (under permanent employment contract)
  • Productization of proton therapy system (2008 - 2010)
    Line management and engineering activities (under permanent employment contract)
  • RPTC proton therapy facility in Munich (2002 - 2008)
    Project management, development, testing/V&V, medical product registration, and tender response activities (under permanent employment contract)
  • NPTC/FHBPTC proton therapy facility at MGH, Boston (1997 - 2002)
    Project management, development and testing/V&V activities (under permanent employment contract)

Publications

  • S. Schmidt, J. Heese, "Technical Commissioning - A Cost Driver in Particle Therapy", PTCOG 48. Meeting of the Particle Therapy Co-Operative Group. Heidelberg, 28.09.-03.10.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. Doc09ptcog178
    Published: 24-Sep-2009
    DOI: 10.3205/09ptcog178, URN: urn:nbn:de:0183-09ptcog1787  
  • S.Schmidt, "Commissioning a Scanning System", PTCOG 46, Meeting of the Particle Therapy Co-Operative Group, Wanjie, 18.-23.05.2007.
    Presentation 19-May-2007
    schmidt_may_19.pdf
  • S. Schmidt, H. Göbel, J. Heese, U. Klein, D. Krischel, M. Schillo, "Concept and Performance of the RPTC Gantry Systems", Proceedings of the Gantry Workshop 2007, Vienna, 9 -10 March 2007, revised second edition, April 2011
    Concept_and_Performance_of_the_RPTC_Gantries.pdf
  • H. Klein, C. Baumgarten, A. Geisler, J. Heese, A. Hobl, D. Krischel, M. Schillo, S. Schmidt, and J. Timmer, "New superconducting cyclotron driven scanning proton therapy systems", Nucl. Instrum. Methods Phys. Res. B 241, 721–726 (2005).
    http://www.sciencedirect.com/science/article/pii/S0168583X05013108
  • D. Prieels, B. Marchand, B. Bauvir, P. De Crock, G. Gevers, S. Schmidt, G. André, S. Ternier, and Y. Jongen, "The IBA state-of-the-art proton therapy system, performances and recent results", AIP Conf. Proc. 576, pp. 857-860, the CAARI 2000: Sixteenth international conference on the application of accelerators in research and industry, date: 1-5 Nov 2000 , location: Denton, Texas (USA)
    DOI: 10.1063/1.1395438
  • J. B. Flanz, S. G. Bradley, M. Goitein, A. Smith, Y. Jongen, J. Bailey, M. Ladeuze, S. Schmidt, J. Schubert, A. van Meerbeeck, T. Hurn and R. Junge, "Initial equipment commissioning of the Northeast Proton Therapy Center", Proc. of the 1998 Cyclotron conference. (1998).
    Initial_Equipment_Commissioning_of_the_Northeast_Proton_Therapy_Center.pdf

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