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    QAdvis AB
    • START
    • ABOUT US
      • Who we are
      • Partners and associations
      • Company presentation
    • OUR SERVICES
      • Medtech consulting
        • PRRC
        • QA&RA manager for hire
        • Small Business Solutions
        • MDR transfer process
        • IVDR transfer process
      • Medical Devices – Prestudy
        • Requirements analysis
        • Due diligence
        • Regulatory strategy
      • Medical Devices – Development
        • Risk management
        • Software risk management
        • Software validation
        • Software Quality Assurance
        • Quality management systems
        • Unique device identification
        • Product verification and validation
        • Computer systems validation
        • Clinical Evaluations and Clinical Studies
        • Clinical performance evaluations and clinical evidence reports
        • Technical documentation for CE marking
          • GSPR
      • Medical Devices – Manufacturing
        • Process validation
        • Computer systems validation
      • Medical Devices – Market access
        • EU
        • USA
        • Canada
        • Japan
        • China
        • Other countries
        • European Authorized Representative
      • Regulatory – Post-market
        • Internal audits
        • Supplier audits
        • FDA inspections
        • Notified body audits
        • Post market surveillance (PMS)
        • Regulatory surveillance
    • COURSES AND SEMINARS
      • Courses and seminars
      • Previous presentations, seminars and webinars
    • NEWS AND SHARE
      • News
      • Newsletter QAdvis News
      • Publications
      • White papers
    • CAREERS
      • Our open positions
      • QAdvis presentation
    • Menu
    • Newsletter QAdvis News
    • News
    • Publications
    • White papers
    • EU Parliament voted positively to the proposal of postponing the Medical Device Regulation for one yearApril 22, 2020 - 3:27 pm
    • EU Commission working on a proposal to postpone the new Medical Device Regulation for one yearMarch 25, 2020 - 5:45 pm
    • Covid-19 situation statementMarch 20, 2020 - 2:32 pm

    ABOUT US

    Who we are
    Partners and associations
    QAdvis presentation (pdf)

    OUR SERVICES

    Medtech consulting
    Medical Devices – Prestudy
    Medical Devices – Development
    Medical Devices – Manufacturing
    Medical Devices – Market access
    Regulatory – Post-market

    NEWS AND SHARE

    News
    Presentations
    Publications
    Videos 
    White papers

     

    CAREERS

    Our open positions
    QAdvis presentation

    CONTACT

    People
    Addresses

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