Dr. Thomas Schmid

Selbstständig, Medical Device and Regulatory Affairs Consulting, Tech Consult

Utting am Ammersee, Deutschland

Fähigkeiten und Kenntnisse

Regulatory Affairs
Quality Management
Technology and Engineering Management
Medical Device Development
Regulatory Submission
Approval Strategy
Technical File
Product Registration
MDSAP
MDR
IVDR
MDD
IVD
AIMD
Risk Management
FMEA
Usability
Usability Testing
Usability Engineering
Functional Safety
Biological Safety
Software Lifecycle Management
Post Market Survaillance
Clinical Evaluation
Clinical Study
Labeling
UDI
Project management
Process Development
Process Optimization
Process Validation
Product design
Production
Quality Assurance
QMS
ISO 13485
Auditor
Training
GAP analysis
Combination Device
Drug Delivery Systems
Pharmaceuticals

Werdegang

Berufserfahrung von Thomas Schmid

  • Bis heute 11 Jahre und 6 Monate, seit 2013

    Medical Device and Regulatory Affairs Consulting

    Tech Consult

    MDR GAP Analysis, CAPA Handling Revision Technical File Approval Strategy for Medical Devices Regulatory Submission International Registration Medical Devices Project Management for Medical Devices, Drug Delivering Systems, IVD from Idea to Launch Production Process Oprimization and Validation, In Process Testing Supplier Handling and Audit Revision of Quality Management System Audit Preparation, Internal Audits and Training

  • 19 Jahre und 3 Monate, 2003 - März 2022

    Professor and Associate Professor

    University of Applied Sciences Munich, HDBW Munich

    Mechatronics, Material Science

  • 2007 - 2013

    Managing Director (CEO)

    DUALIS MedTech GmbH

    DUALIS is an highly innovative company in the field of medical device development. DUALIS was founded as a Spin-Off company from the German Aerospace Center (DLR) in 2007.

  • 2003 - 2007

    Scientific Project Manager

    University of Applied Sciences Munich

    Fluid Dynamic Investigations by means of Particle Image Velocimetry (PIV) and Laser Doppler Anemometry (LDA), Flow Visualisation, Lectures in Fluid Mechanics and Advanced Fluidmechanics.

  • 1998 - 2007

    Projektmanager

    Institute for Robotics and Mechatronics, German Aerospace Center (DLR)

    Development of a completely implantable bi-ventricular heart assist device with wireless energy supply.

  • 2000 - 2002

    Scientific Project Manager

    Lehrstuhl für Fluidmechanik, Institut für Aero- and Astronautics der Technischen

    Flow Visualisaion in the chambers of a heart assist device, flow measurements in models of the Cortis Arteria with Stents.

  • 1997 - 1998

    Project Manager

    Institute for Robotics and Mechatronics, German Aerospace Center (DLR)

    Development of a novel drive system for implantable heart assist devices.

  • 1991 - 1997

    IT Systems Administrator

    Thomas Schmid

    Software Development, System Administration, Network Solutions, User Training

Ausbildung von Thomas Schmid

  • 1991 - 1997

    Mechanical Engineering

    Technical University Munich

  • 1989 - 1991

    Business informatics

    Chamber of Industry and Commerce (IHK), Munich, Germany

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Grundlagen

21 Mio. XING Mitglieder, von A bis Z