Regulatory Open Forum

 View Only

  • 1.  IEC 62304 and mobile app

    This message was posted by a user wishing to remain anonymous
    Posted 14-Feb-2019 08:13
    This message was posted by a user wishing to remain anonymous

    Hi everyone

    For clarification, does a mobile interface with any other system. In Clause 5.2.2 software requirements section, interface between the software system and other systems, does this apply to mobile apps?  Thanks


  • 2.  RE: IEC 62304 and mobile app

    Posted 14-Feb-2019 10:54
    Yes, there's no reason why it wouldn't apply, just because it's a mobile app... Mobile apps can have interfaces, too.​
    Of course some interfaces are more important than others with regard to safety.

    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 3.  RE: IEC 62304 and mobile app

    Posted 16-Feb-2019 17:43
    There may be interfaces such as local database, API, your central database/cloud, interfaces with hardware components if you're using the mobile device sensors (e.g. accelerometer) or camera to capture data, or interfaces with other medical devices or services from which you collect information for analysis.

    ------------------------------
    Michael Zagorski RAC
    Pittsburgh PA
    ------------------------------

    Original Message


Related Content