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Experiences

Current Experience

  • Member of the Evaluation Commission Medical Devices in Belgium


    Since May 2010
    evaluation of Medical Device vigilance notifications in belgium evaluation/advice in notifications of pre-market Clinical studies (Medical Devices) evaluation of market surveillance issues on Medical Devices. technical Expert electro-Medical Devices technical Expert medical Software Evaluation of medical device vigilance notifications in Belgium Evaluation/advice in notifications of pre-market clinical studies (medical devices) Evaluation of market surveillance issues on medical devices. Technical expert electro-medical devices Technical expert medical software

  • Product Manager Medical Devices


    Since February 2007
    working for notified body Medical Devices 0120 (sgs u.k.) working for notified body Medical Devices 1639 (sgs belgium) Working for Notified Body Medical Devices 0120 (SGS U.K.) Working for Notified Body Medical Devices 1639 (SGS Belgium)

  • Lead Auditor


    Since February 2007
    Medical Devices Software Electronics Medical Devices Software Electronics

Past Experience

  • Project leader medical devices

    March 2007 --- July 2010
    Testing, evaluation of test reports and certification of electro-Medical Devices according to en iec 60601 (second and third edition)

  • Software Engineer/Architect (medical software)

    October 1997 --- February 2007
    technical Software for Clinical, microbiological and Hospital laboratoria. Laboratory information management system

  • Hospital physicist (Radiotherapy)

    September 1995 --- September 1997
    Research on filmdosimetry as Quality Control of the radiotherapy Treatment radiotherapy Treatment Planning

  • Hospital physicist (Radiotherapy): trainee

    July 1995 --- September 1996
    calibration of linear accelarators (radiotherapy) Quality Assurance and calibration of radiotherapy equipment radiotherapy Treatment Planning of patients dosimetry

Knowledge

LinkedIn Assessment :
IT AuditCompliance AuditsAuditingExternal AuditISO 13485CE markingQuality SystemsQuality AuditingQuality SystemsISO 14971IEC 60601Technical FilesCMDCASMedical DevicesTestingClinical researchQuality Assurance (QA)R&DCAPAValidation

Education

  • Master in Biomedical and clinical engineer from Catholic University of Leuven (Belgium) in 0000
  • Master degree in mechanical-electrotechnical engineer from Catholic University of Leuven (Belgium) in 0000

Area / Region

Antwerpen, België

Others

Driving License
  • No

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