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Cédric BOESCH

AGIEZ

En résumé

I m a biomedical engineer specialized in biomechanics, quality and regulatory affairs. My experience is built on CE marking of medical device and designing quality management systems. I'm a trained auditor for ISO13485 and ISO 9001 and expert in structuring and maintaining regulatory technical files for the CE marking process. This includes design transfer activities such as process validation. I hold a biomedical engineering degree from ISIFC in Besançon and a European degree 3 in sterilization of medical devices.

Spécialisations :Biomedical engineer, Quality management system specialist, ISO 9001 & ISO 13485 compliance, Auditor of QMS based on ISO 9001:2008 and ISO 13485:2003, Mastery of the standard for clinical investigation (ISO 14155:2011), WFHSS (European Forum for Hospital Sterile Supply) level III

Entreprises

  • Medidée Services - Medical Devices and QMS Expert

    2010 - maintenant Missions:
    • Management of 510(k) submission for active medical devices with preparation of complete technical file based on FDA requirements.
    • Project management and team management with 41 legal manufacturers and management of the relation with suppliers.
    • Management of international submissions for ophthalmic implants and instruments
    • Implementation of quality management systems based on ISO13485 compliance and 21 CFR.
    • Implementation of technical and manufacturing documentation based on the MDD 93/42 (class I, IIa, IIb and III devices) and PPE 89/686 (Personal Protective Equipment) for CE Marking
    • Implementation of Verification & Validation process for hardware and software devices
    • Implementation of risk management plan based on the ISO14971 and CAPA systems
    • Management of internal and suppliers audits
    • Update of documents as per the new requirements of the standard ISO14155
    • Implementation of technical files for OEM-OBL procedures.
    • Support services to obtain authorizations to start clinical evaluations with SwissMedic

    Main business areas:
    • Ophthalmic devices (implants and tooling), Switzerland
    • Spinal implant, France and Switzerland
    • Kit for medical application, Switzerland
    • Contract Research Organization (CRO), Switzerland
    • Surgical device for orthopedic application, Switzerland
    • Pill for diagnosis of the digestive system, Switzerland
    • Implant for deep brain stimulation therapy, Switzerland
    • Image fusion in urological interventions, France
    • Software for detection and localization of tumors at diagnostic stage, Switzerland
    • Dental implant, Switzerland
    • Sterilization, Switzerland
    • ECC canula for cardio-thoracic surgery, Switzerland
    • Protective mask for medical application, Switzerland

  • Philippe Etter Conseil - Regulatory Affairs & Quality Assurance Consultant

    2010 - maintenant • Biomedical engineer
    • Quality management system specialist
    • ISO 9001 & ISO 13485 compliance
    • Auditor of QMS based on ISO 9001:2008 and ISO 13485:2003
    • Mastery of the standard for clinical investigation (ISO 14155:2011)
    • WFHSS (World Forum for Hospital Sterile Supply) level III

  • Eden Spine Europe - Junior Project Manager

    2009 - 2009 - Project management towards CE marking of Eden Spine Europe (Spine implant manufacturer in Geneva):
    • Design of technical file for CE marking, CE obtained
    • Internal auditing
    • Modifications of Quality Management System
    • Design and management of lab testing for verification & Validation (V&V)
    • Support during certification audit

    - Commercial support at NASS (North American Spin Society) show in San-Francisco.

    - Commercial support at SAS (Spine Arthroplasty Society) show in London.

  • Centre d'Investigation Clinique en Innovation Technologique (CIC-IT) de Besancon (Dr Lionel Pazart) - Stagiaire

    2008 - 2009 Stage ayant deux objectifs complémentaires. Le premier consistant à développer, en collaboration avec des chirurgiens, un dispositif permettant de délivrer de la salive artificielle à des patients atteints de sécheresse buccale.
    Le second permettant la mise en place d'une pré-étude clinique destinée à mesurer l'évolution de la mouillabilité de la salive suite à une irradiation.

  • Hôpital Jean Minjoz de Besançon, Service de chirurgie thoracique et cardio-vasculaire - Stagiaire

    2007 - 2007 - Étudier et remédier à un phénomène de recirculation au niveau des valves cardiaques lors d'une circulation extracorporelle d'assistance respiratoire veino-veineuse (ECMO).

    - Réalisation du dossier de marquage CE d'une canule innovante en cours de développement.

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