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Medical Device Standards and Regulations

Medical Device Standards and Regulations

  1. ISO 13485 and ISO 14969 – Medical Devices QMS

    ISO 13485 and ISO 14969 – Medical Devices Quality Management System
    Discussions:
    101
    Messages:
    614
    Latest: ISO13485 Clause 8.3 and Sub-Clause 8.3.2 and 8.3.3 Andy Nichols, Nov 1, 2023
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  2. ISO 14971 - Medical Devices Risk Management

    ISO 14971 - Application of Risk Management to Medical Devices
    Discussions:
    6
    Messages:
    50
    Latest: Certification to ISO 14971 ? Quality Manager Liz, Dec 8, 2017
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  3. IEC 60601 - Medical Electrical Equipment Safety

    IEC 60601 - Medical Electrical Equipment Safety Standards Series
    Discussions:
    21
    Messages:
    71
    Latest: Defining a lower ESD test limit for 60601 test Wins Letshawn, May 16, 2022
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  4. IEC 62304 - Medical Device Software

    IEC 62304 - Medical Device Software - Software Life Cycle Processes
    Discussions:
    7
    Messages:
    33
    Latest: IEC 62304 for developer tools that are packaged with final product. yodon, Aug 30, 2023
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  5. IEC 62366 - Medical Devices Usability Engineering

    IEC 62366 - Application of Usability Engineering to Medical Devices
    Discussions:
    2
    Messages:
    8
    Latest: Usability procedure yodon, Apr 3, 2018
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  6. Canada Medical Device Regulations

    Canada Medical Device Regulations
    Discussions:
    1
    Messages:
    6
    Latest: CMDCAS addition to ISO 13485 OrangeIsEnergy, Aug 25, 2015
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  7. China Medical Device Regulations

    China Medical Device Regulations
    Discussions:
    5
    Messages:
    23
    Latest: New China RoHS Regulation [Effective on July 2016] QAengineer13, Apr 29, 2016
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  8. EU Medical Device Regulations

    European Union Medical Device Regulations
    Discussions:
    39
    Messages:
    154
    Latest: EU MDR transitional period extension bozidar, Mar 6, 2023
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  9. US Medical Device Regulations

    United States Medical Device Regulations
    Discussions:
    26
    Messages:
    88
    Latest: Dropping MDSAP? Jennifer Kirley, Mar 13, 2023
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  10. Other Medical Device Regulations World-Wide

    Other Medical Device Regulations World-Wide
    Discussions:
    16
    Messages:
    44
    Latest: Brazil / Japan: Essential Safety and Effectiveness Requirements MaxiFuer, Sep 15, 2019
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