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  • 1.  SaMD Installed on a Laptop

    This message was posted by a user wishing to remain anonymous
    Posted 10-Sep-2020 09:05
    This message was posted by a user wishing to remain anonymous

    I have a few questions associated with SaMD that is shipped installed on a laptop.  Clause 5.8.8 of IEC 62304 states the following: 

    The MANUFACTURER established procedures to ensure that the released MEDICAL DEVICE SOFTWARE can be reliably delivered to the point of use without corruption or unauthorised change

    These procedures addressed the production and handling of media containing the MEDICAL DEVICE SOFTWARE including as appropriate:
    replication, media labeling, packaging, protection, storage, delivery.

    Considering these clauses and other regional regulatory requirements, I have the following questions:
    • Will these requirements apply to a laptop that is being shipped within state to state in the US and other countries with the medical device software installed on it?
    • Will the laptop need a physical label that identifies the medical device software it is carrying?
    • Since the laptop is being shipped with the SaMD installed, does that make the laptop a medical device? If so, would it need to comply with the IEC 60601 electrical safety and EMC testing requirements? 
    I would really appreciate insight from fellow RAPS members on this. Thank you.


  • 2.  RE: SaMD Installed on a Laptop

    Posted 11-Sep-2020 05:39
    Hello Anon,

    The whole aspect of a Software as a Medical Device - SaMD - is exactly what is described that is a software only product.  The requirements around a SaMD should be platform agnostic meaning the software is designed to work on minimum requirements for a system, i.e. RAM, CPU, processors, memory, video.  It should not matter what is the laptop, type of laptop, or even if shipped with a laptop - it is about the requirements the system is needed for the software.  Whether the laptop is considered as a medical device is really how you define the "system" because if say the SaMD software is only required and can only run on that type of laptop, then maybe it needs to be considered.  However, in general often the actual computer, laptop, smart device is not considered the medical device since it is only being used to run the software - though again the system may require a specific type of computer device to run, so this needs to be clearly stated in the Product Specifications and the Software Architecture Design.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: SaMD Installed on a Laptop

    This message was posted by a user wishing to remain anonymous
    Posted 11-Sep-2020 16:13
    This message was posted by a user wishing to remain anonymous

    If the laptop could have an effect on how the SaMD functions, you may want to consider an impact analysis per FDA's Multiple Function Product guidance. FDA just did  webinar on it yesterday. 

    But since the laptop doesn't on its own have a medical purpose, it is unlikely to be considered a medical device.
    Original Message


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