Jonas Gamstedt

Quality and Regulatory Affairs Consultant. Partner at Berotec and owner of Mandatech.

Plats: Stockholm County, Sweden

Nyckelord: QA-management, Stockholm, Systemarkitekt, Testledare

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Sammanfattning

I have more than ten years experience from development of highly complex products containing mechanics, electronics and software. My experience ranges from test and quality assurance methodology, design of automated test and measurement systems and project management to an extensive knowledge of the regulatory environment the concerns the medical devices industry. I have been responsible for type certification and CE-marking of several medical devices.

I have an unusual ability to comprehend and analyse complex information. Combined with excellent teaching skills this makes me an invaluable member of any project e.g. as moderator for risk analysis and design workshops. I have the ability to make people work efficently and creatively together.

Kompetenser

CE-marking, type testing, IEC 60601, UL 60601, UL2601, ISO13485, ISO 14971, QSR, MDD, MD, LVD, Risk analysis, automated test and measurement, regulatory affairs, project management

Erfarenhet

  • Partner

    Berotec 2008 –

    Associated with Berotec, a network of highly skilled and motivated senior independent consultants.

    Quality Assurance services e.g. Project management, Test systems architect, risk analysis, process development.

    Reulatory affairs specialist, primarily within the medical devices and life science domain. CE-marking according to MDD, MD, LVD. Coordination of certification and type testing.

  • Owner

    Mandatech 2008 –

  • Quality Development Engineer

    Sectra Mamea AB 2004 – 2008

    Regulatory affairs, quality management system develpment and certification, product certification, CE marking. Project management.

  • Test System Architect

    Teleca System Design 2000 – 2004

    Automated test and measurement. Labview, Teststand, data aqcuisition, instrument control.

  • Applications Engineer

    National Instruments 1998 – 2000

    Customer support, customer training, sales support.
    LabView, LabWIndows/CVI, Teststand, data aqcuisition, instrument control.

Utbildning

  • Electrical Engineering

    Lunds tekniska högskola 1993 – 1998

Stockholm County, Sweden