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Sumi Kandel

Sumi Kandel

Registered Nurse

Followers of Sumi Kandel128 followers
location of Sumi KandelDenver Metropolitan Area

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  • Timeline

  • About me

    Medical Device Regulatory Professional

  • Education

    • College of medical sciences

      -
      Bachelor's degree Registered Nursing/Registered Nurse

    • Simmons University

      2021 - 2026
      Master's degree

  • Experience

    • Various Companies

      Jul 2016 - May 2021
      Registered Nurse

    • Independent Consultant

      Jul 2021 - May 2023
      Consultant

      Medical DeviceSAPeTMFComputer System ValidationInformation System

    • Philips

      Jul 2022 - now

      Regulatory labeling PlanCAPABartender softwareEnlabelRegulations and Standards Project Management Design SpecificationsRequirement specifications International standards ( IEC60601, ISO14971, ISO15223, ISO 20417) EU MDR 2017/745Labels and IFU/Operator manuals updatesChange controlWindchillInstallation Qualification Box / Carton graphicsReceiving Inspection Plans and Purchase Specifications Country Specific Localized Labels and IFUsRebranding Patient Implant Card (PIC)New Product Development

      • Regulatory and Labeling Specialist

        May 2023 - now

      • Regulatory Labeling / Change Management Consultant

        Jul 2022 - May 2023

  • Licenses & Certifications

    • Regulatory Affairs Certificate: Medical Devices

      Regulatory Affairs Certification Program
      Dec 2023
      View certificate certificate

    • Hands-on Data Science and AI for Healthcare

      LinkedIn
      Feb 2025
      View certificate certificate

    • ISO 13485

      Udemy
      Apr 2022

    • EU MDR

      Easy Medical Device