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Thomas QUEUCHE

CHAPONOST

Electionseuropéennes 2024

RETROUVEZ GRATUITEMENTLe résultat des européennes à Sallanches ainsi que le résultat des européennes en Haute-Savoie.

En résumé

Mes compétences :
Solidworks
Microsoft Word
Microsoft PowerPoint
Microsoft Office
Microsoft Excel
Medical Devices
Regulatory Affairs

Entreprises

  • SYMATESE - Assistant ingénieur en affaires réglementaires et en R&D

    CHAPONOST 2015 - 2015 Regulatory affair tasks carried out:
    - Research inputs data through legislations and guidelines from different non-European countries (Brazil, Mexico, Colombia, South Korea, Australia,…) to register class III medical devices
    - Update files and documents for technical file
    - Regulatory and normative monitoring
    - Risk analysis following ISO 14971 : AMDEC product (seriousness, probability, detection, method to reduce risk)

    R&D tasks carried out:
    - List of verification test for a preclinical assessment
    - Study about chemical characterization of different products: GPC, FTIR, GC/MS, Gravimetric analysis
    - Stability studies and writing protocols for real time and accelerated aging (shelf life determination)
    - Writing protocols about mechanical testing for routine control
    - Product and purchase specifications

  • Centre d'investigation clinique en innovations technologique - Assistant ingénieur en R&D

    2014 - 2014 - Technical and functional specifications : requirement analysis, technical specification characterizations, FAST (Function Analysis System Technique) diagram
    - Regulatory and normative monitoring
    - Preliminary risk analysis following ISO 14971
    - Chemical and mechanical studies of the product
    - Computer aided design with SolidWorks 2014 to obtain a realistic representation of the device

Formations

  • Université Bordeaux 2 Victor Segalen

    Bordeaux 2013 - 2015 Master (Msc) biomatériaux et dispositifs médicaux

    Medical devices analysis: Design approach, functional and technical needs, risk analysis

    Regulatory: Technical file on class IIa, IIb and III medical devices (Classification, standards, risk analysis, conformity with the essential requirements of European directive 93/42/CEE), Quality approach, standards, European and international directives (USA, Canada, Brazil, CE marking)

    Biology, mechan

  • Université Bordeaux

    Bordeaux 2010 - 2013 Licence

    Licence 3 BMCP (Biologie moléculaire, cellulaire et physiologie)

Réseau

Annuaire des membres :