Dr. Thomas Schmid

Partner / Gesellschafter, Senior Lead Consultant Medical Device, TechConsult GmbH
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 13 Jahre und 1 Monat, seit 2013

    Senior Lead Consultant Medical Device

    TechConsult GmbH

    Medical Device Development, Regulatory Affairs Consulting, Design Assurance, Project Management for Medical Devices, Drug Delivering Systems, IVD, Lead Auditor ISO 9001 and ISO 13485, Audit Preparation, Internal Audits and Training

  • Teaching and research area: Robotics and Mechatronics

  • Mechanical Engineering and Fluidmechanics

  • 2008 - 2013

    Managing Director (CEO)

    DUALIS MedTech GmbH

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

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

  • 1997 - 2007

    Mechanical Engineering, Project and Team Leader

    Deutsches Zentrum für Luft- und Raumfahrt e.V.

    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.

  • 2000 - 2002

    Scientific Employee

    TU München

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

  • 1989 - 1991

    Engineering Trainee

    Dorst Technologies

Ausbildung von Thomas Schmid

  • 1991 - 1996

    Mechanical Engineering

    TU München

  • 1989 - 1991

    Business Informatics

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

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Grundlagen

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