Regulatory Open Forum

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  • 1.  Shelf-Life Testing

    Posted 19-Jan-2017 00:05
    Hello All,

    Is shelf -life testing required for all medical devices?
    Is shelf-life testing applicable only to sterile devices. Are there existing guidance documents for shelf-life of medical devices.
    All the inputs in this direction is truly appreciated.

    Thanks,
    Aliva Das.