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Clément ValloisCV

Clément Vallois

Medical Device Consultant

€700/day
Grenoble, FR
15+ years

Average response time: 1 hour

Freelancer profile translated to English.
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About Clément

My various professional experiences in the field of medical devices (pacemakers, radiology, artificial heart, infusion pumps, etc.) have allowed me to confront numerous technical and human challenges, to work in companies of different sizes, and to familiarize myself with the regulatory (CE and FDA) and normative (ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, IEC 62366-1...) constraints of medical device development.

My various experiences enable me to lead the development of complex medical devices from specification to post-market surveillance with the support of multidisciplinary teams and subcontractors, while respecting deadline/budget/quality constraints.

Ensuring patient safety by limiting use errors and improving the user experience for medical personnel has, in recent years, become a major concern for medical device manufacturers. This is why I have developed my expertise in usability engineering (human factors).

My various management experiences allow me to respond to the different challenges of an organization and to bring large-scale projects to fruition: growth, performance improvement, crisis management, interim management…
  • French

    Native or bilingual

  • English

    Fluent

Can work on-site
Grenoble (up to 50km)

Experience

  • DIABELOOP
    Head of Technical Care Team
    January 2023 - Today (3 years and 5 months)
    Grenoble, France
    Management of the Technical Care team, responsible for technical support and complaints for patients equipped with the Diabeloop system. Restructuring of processes and organization of the team. Merging of the Technical Care and Complaints teams. Management of a team of 8 people. Participation in post-market surveillance. Additional missions:
    - 4-month audit of the production department
    - Lead of pre-submission and support for the FDA submission of the DBLG2 project
    - Management of the FDA pre-submission for the DBL-4pen project
  • Indépendant
    Usability/Human Factors Consultant (IEC 62366-1, FDA Guidance)
    January 2019 - Today (7 years and 5 months)
    Vinay, France
    Consulting and training for companies developing medical devices to implement and optimize the usability engineering process and strategy for CE marking or US market entry.
  • UroMems
    System Team Lead
    June 2021 - January 2023 (1 year and 7 months)
    Grenoble, France
    System specification and architecture. Risk management. Usability. Technical support for surgeons. Management of accompanying documents (user manual, technical manual). Management of 4 people.

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Education

  • Diplôme d'ingénieur, Ingénierie biomédicale / médicale
    Université de Technologie de Compiègne
    2005
    Diplôme d'ingénieur, Ingénierie biomédicale / médicale
  • Chine - Travailler avec des Chinois, Interculturalité
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    2019
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Skill set

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