Regulatory Open Forum

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  • 1.  Discontinuation/Obsolescence Procedure

    Posted 22-Jul-2019 22:18
    Does anyone have a basic SOP to discontinue or obsolete a medical device from commercial distribution?  I'm fairly comfortable with the Regulatory aspects, but would like some ideas about actions/considerations for other functions throughout the organisation. 

    Thanks!

    Tina

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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  • 2.  RE: Discontinuation/Obsolescence Procedure

    Posted 23-Jul-2019 11:41
    I can't send you my procedure here is what we would look at when obsoleting a product (we have not yet done this, so if anyone sees any holes I would love the feedback).

    Review the following:
    BOM/MOM
    status of units in the field
    current open complaints
    status of any recalls (if applicable)
    DMR/DHF
    CAPAs/Investigations
    Supplier relationships
    Inventory status
    POs yet to be filled
    current demand and forecasts
    Purchasing - final buys (how long will we be supporting the product after obsolescence)

    I hope this helps you.

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    Keri Froese RAC
    Quality Assurance Manager
    Dunrobin ON
    Canada
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  • 3.  RE: Discontinuation/Obsolescence Procedure

    Posted 23-Jul-2019 16:43
    Awesome - thanks Keri!

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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