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  • 1.  Laptop testing as a medical device for CE marking

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jun-2021 08:38
    This message was posted by a user wishing to remain anonymous

    Dear RAPS members,

    I need help in understanding standards that would apply to a laptop used to run a medical device software. The SW on the laptop will be used by medical professionals for treatment planning. I am thinking of the following standards: 62366 and IEC 62304, IEC 62368. Do EMC and electrical safety standards apply even if the laptop is already CE marked by the vendor ?

    Thanks and best regards




  • 2.  RE: Laptop testing as a medical device for CE marking

    Posted 08-Jun-2021 14:27
    It depends. Is it intended to be used in an office environment? Is it intended to be connected to medical equipment?​ How will it be classified? What risks do you need to control?

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Laptop testing as a medical device for CE marking

    Posted 08-Jun-2021 15:01
    "laptop used to run a medical device software"

    I agree with what Anne has stated but have to ask if this laptop is provided to the software user exclusive of their own hardware? If this laptop fails they must RMA it and wait for a replacement? Is there something unique about this laptop? May they run the software on their own hardware? Do you provide periodic cybersecurity updates? Will you allow their IT group to scan it for viruses?

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


  • 4.  RE: Laptop testing as a medical device for CE marking

    This message was posted by a user wishing to remain anonymous
    Posted 11-Jun-2021 08:52
    This message was posted by a user wishing to remain anonymous

    Thanks, Anne, Ed, and all for the response and questions. The laptop is used by the clinicians in a hospital office setting. It does not connect to any medical device other than the hospital PACS. Treatment plans are created based on DICOM images and exported to a DVD/CD drive. The SW runs only on the provided laptop, and the laptop is tested for Cybersecurity.
    Original Message


  • 5.  RE: Laptop testing as a medical device for CE marking

    Posted 09-Jun-2021 04:12
    Hello,

    Are you a software manufacturer? I recommend staying away from supplying hardware if possible. Just specify a minimum specification and let the customer buy it.

    David

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    David Clafton
    Mirada Medical
    Oxford
    United Kingdom
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    Original Message


  • 6.  RE: Laptop testing as a medical device for CE marking

    Posted 09-Jun-2021 05:10
    Hello,

    I agree with David, just provide recommendations on the "minimum system requirements" and let the users source their own hardware.  Though with that said, many regulators have taken the stance of standard computing equipment would not be regulated, e.g. computers, screens, printers, inputs, etc.  This does depend on the type of device because of the medical device software is an imaging platform which requires specific video card or specific monitor, then these may need to be part of the "system."  Anne raises good questions which should be part of the system description, product requirements document, and risk management.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


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