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Mobile Scooters Classification

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Eloisa Hufana, Feb 13, 2024.

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  1. Eloisa Hufana

    Eloisa Hufana New Member

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    Good day!

    May I clarify please if mobile scooters are considered as class 1 device in Canada? Does it require an ISO 13485 certification? Thanks!
     
    Eloisa Hufana, Feb 13, 2024
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  2. victorsyj

    victorsyj New Member

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    victorsyj, Feb 19, 2024
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    Eloisa Hufana likes this.
  3. Eloisa Hufana

    Eloisa Hufana New Member

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    Appreciate on your confirmation on the classification.

    May I ask if it is required to have a completed prototype or that the company has been operational for 3 months before we can apply for MDEL please? Thanks
     
    Eloisa Hufana, Feb 19, 2024
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