Dr. Thomas Schmid

Bis 1991, Engineering Trainee, Dorst Maschinen- und Anlagenbau
Bernried am See, 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 12 Jahre und 11 Monate, seit 2013

    Medical Device Development, Regulatory Affairs Consulting

    Tech Consult GmbH

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

  • 2008 - 2013

    Managing Director (CEO)

    DUALIS MedTech GmbH

    DUALIS is an highly innovative company in the field of medical device development.

  • 1997 - 2008

    Scientific Employee, Project and Team Leader

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

    System development for innovative robotic solutions, energy transfer, material science, spin-off projects for medical devices, coordination with industrial partners and research institutions, patent management.

  • 2005 - 2007

    Scientific Employee

    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.

  • 2000 - 2002

    Scientific Employee

    Technical University Munich, Chair if Aerodynamics and Fluid Mechanics

    Research projects in the field of bio-fluid mechanics, Supervision of exercises and examinations at the Chair of Fluid Mechanics, Faculty of Mechanical Engineering.

  • 1991 - 1997

    IT Systems Administrator

    Thomas Schmid

    Software Development, System Administration, Network Solutions, User Training

  • 1989 - 1991

    Engineering Trainee

    Dorst Maschinen- und Anlagenbau

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

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