Distributed By Product - Best Practices for Configuration Management and Purchasing Controls

William55401

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#1
Hello Cove! I am mostly a responder to questions. However, today, I am seeking your input on control of "distributed by" product. I searched prior threads and did not find any hits.

The question / the ask. For medical devices that are labelled "distributed by" or "manufactured for" where another entity owns the design and regulatory approval pathway, how does the distributor best control the configuration of what they purchase and distribute? How detailed are your specifications? Do you even have specifications? Can I get by with just a controlled item master in my ERP system that defines what I am buying from the device manufacturer? Is there a lean and compliant way to leverage configuration controls at the device manufacturer and minimize the QMS burden on the distributor? Can the product configuration all be handled in contracts / agreements that include specific configurations maintained by the device manufacturer?

I am curious how others are approaching product configuration and purchasing controls in the "distributed by" space. Thank you for your help.
 
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