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Petitjean AUDE

Strasbourg

En résumé

Mes compétences :
Programmation Matlab
Base de données Access
Certification ISO 13485
Gestion de Projet Gantt
Directive 93/42/CEE
510k FDA
Programmation html, css
Risk management ISO 14 971
EN IEC 62304 (software)

Entreprises

  • Visible Patient - Quality and regulatory affairs manager

    Strasbourg 2013 - maintenant Visible Patient offers an online service for surgeons, oncologists or radiologists who need to have a personalized 3D modeling of a patient to efficiently plan his/her therapy.
    - put in place the Quality Management System according to the standard ISO 13485 (write, supervise, participate and validate all quality documents),
    - in charge of regulatory affairs for software,
    - application of the IEC 62304, ISO 14971.

  • ONEFIT MEDICAL - Engineering internship in regulatory affairs

    2013 - 2013 OneFit Medical develops and commercializes software and surgical instruments providing patient specific solutions for orthopaedic surgery.
    - constitution of the technical file and validation of a new software for its CE marking,
    - constitution of a 510k procedure for the placing on the US market of a software and cut guides already used in Europe.

  • McGill University - Research internship in laboratory

    2013 - 2013 Near-infrared spectroscopy (NIRS) is a technique of diffuse optical imaging used to study neural activity in the human brain. It is based on the measurement of the absorption and scattering of near-infrared light by biological tissues. The new system acquire by the laboratory allows to follow, thanks to red light emitting sources and detectors placed on the scalp, the brain hemodynamic activity.
    Missions: validation of data acquiered by the device
    - realisation of protocols,
    - acquisition of data during completely controlled protocol such as a motor task or a sensory stimuli of the median nerve,
    - images processing for the interpretation of results.

  • OneFit Medical - Engineering internship in regulatory affairs

    WASHINGTON DC 20005 2012 - 2012 OneFit Medical develops and commercializes software and surgical instruments providing patient specific solutions for orthopaedic surgery.
    Missions :
    - writing technical file and clinical evaluation reports applied to software,
    - performing tests of qualification,
    - prior searches.

  • CHU Minjoz, service de chirurgie thoracique et cardiovasculaire - Engineering internship in hospital

    2012 - 2012 The internship took place at the service of thoracic and cardiovascular surgery.
    Missions :
    - determination of specifications for the implementation of an iPad for the computerization of extracorporeal circulation,
    - writing the requirement specifications,
    - determination of solutions for the implementation of the specifications.

Formations

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