ISO 13485 for a Distributor

Brizilla

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#1
We're an On-Demand fulfillment and distribution company. A potential customer is discussing a potential $2M dollar deal with us but wants us to go 13485. We just got our ISO certification 2 months ago. What are the differences between us as a distributor vs a medical device manufacturer in implementing the standard? Should I try to find a consultant that is knowledgeable about this?
 
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LUFAN

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#2
You got your ISO 13485 certification two months ago? Or some other certification?

If you're taking on contract manufacturing, obviously a large chunk of clause 7 becomes applicable to your organization that probably would have been listed as N/A before or would have been more insignificant (Purchasing for example). A consultant is an okay approach to achieve the gap, but maintenance is far more tough. If this is referring to manufacturing, you will most definitely want to hire a couple MedDev quality professionals to support the QMS and specifically product realization.
 

Sidney Vianna

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#3
We're an On-Demand fulfillment and distribution company. A potential customer is discussing a potential $2M dollar deal with us but wants us to go 13485. We just got our ISO certification 2 months ago. What are the differences between us as a distributor vs a medical device manufacturer in implementing the standard? Should I try to find a consultant that is knowledgeable about this?
Scroll down the page and you will see a number of similar discussions.
 

Brizilla

Quite Involved in Discussions
#5
You got your ISO 13485 certification two months ago? Or some other certification?

If you're taking on contract manufacturing, obviously a large chunk of clause 7 becomes applicable to your organization that probably would have been listed as N/A before or would have been more insignificant (Purchasing for example). A consultant is an okay approach to achieve the gap, but maintenance is far tougher. If this is referring to manufacturing, you will most definitely want to hire a couple MedDev quality professionals to support the QMS and specifically product realization.
No manufacturing at all. We are a fulfillment and logistics company. We would essentially be taking in stock from a customer, storing it in bulk, and then piecemealing it out to companies or people ordering it.
 

Sidney Vianna

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#6
Last edited:

John C. Abnet

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#7
Good day @Brizilla

Relevant to your question...
4.1.1 statesThe organization shall document the role(s) undertaken by the organization under the applicable
regulatory requirements.
NOTE Roles undertaken by the organization can include manufacturer, authorized representative, importer
or distributor.

Based solely on your original post, all of 7.3 and much of 7.5 would not apply to your organization. A COMPETENT / proven consultant can indeed be a significant asset ...particularly to ensure your management system does not "balloon" into a monster beyond what benefits your organization.

Hope this helps.

Be well.
 
Last edited:

Brizilla

Quite Involved in Discussions
#8
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