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Surgical Instrument Supplier-Certification?

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  • Posted by: StuW
    Posted on: Tuesday, 13th October 2009, 3:11 PM.



    A caveat to begin.  I worked in the electronics industry for many years, not the health industry.   I don't know if regulations exist, or not, however, your company should have guidelines to address dealing with sub-contractors or suppliers, and I suggest you start with those.   In my industry, we would not deal with suppliers who would not enter into a relationship with us that required supplier audits, and/or data with incoming shipments.   Typically, once a supplier was evaluated and approved, the amount of data requested of them would be determined and then reviewed based upon their performance.   Good performance over many shipments would result in the potential for less data required with future shipments. 

    In your instance, the data should meet the quality standards that you expect of your own manufactured products, no less.  You should define those characteristics that are truly important and ask for this data to evaluate the supplier, including reviews of their data and production methods.  This should lead to a decision on whether to accept product or not from this supplier.


     Message Thread:
      Surgical Instrument Supplier-Certification? by KB on Tuesday, 13th October 2009
           Re: Surgical Instrument Supplier-Certification? by StuW on Tuesday, 13th October 2009


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