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  • smitshah replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 7 years, 6 months ago

    I think that it worth buying this standards from regulatory department because if they are the one who are gonna finally approve our product for sales if the device specs are not withing the device specs as they have suggested that might lead to more scrutiny of the device approval.

    Different ISO standards are charged differently when it comes to medical devices there are ISO like 17664,1160,11135 etc
    The cost ISO 2626 for electrical safety is USD 2000 its the cost off all the document combined which leads to high charges and not the individual once.
    I think if they would sell this as bundle package than it would cost bit less but for a reason they know all company would buy there document even if they sell separately.
    ISO itself needs buildings, and all the costs associated with those.Basically, there is a large overhead in running a standards organization which is not attributable to any single standard. Which leads them to charge this much.