Education

Previous Lectures

Classification of Medical Devices

Naoki Morooka ┃ Japanese Medical Imaging and Radiological Industry Association (JIRA)


About the Speaker

  • Name

    Naoki Morooka

  • Institute

    Japanese Medical Imaging and Radiological Industry Association (JIRA)

  • Department

    Regulatory and Safety Division

  • Position

    Vice Division Chair

  • Economy

    Japan

  • Contact Information

    morooka@shimadzu.co.jp

  • A brief history

     

  • Mr. Naoki Morooka is director for medical device regulations as Senior General Manager of Medical Regulatory Policy Department of SHIMADZU CORPRATION. He is working in SHIMADZU CORPRATION more than 30 years as the expert of RA, QMS and Product Safety of Medical Devices. He is also Vice Division Chair of Regulatory and safety in Japanese Medical Imaging and Radiological Industry Association : JIRA. 

    GHTF(Global Harmonization Task Force) Study Gruop1 member as the representative of Japanese Industries (2002-2012). 
    A board member of DITTA (2018-)
    IMDRF(International Medical Device Regulators Forum) RPS WG (2012-) and Standards WG (2016- 2020) as the representative of DITTA. 
    A expert member of ISO/TC 210 and WG1, WG2, WG7as the representative of Japanese Standards National Committee(JISC).