Contract Manufacturing Company - What does contract manufacturing company mean?

invitro_spain

Involved In Discussions
#1
Hi all,

It is my first post in the Forum and I need help!. I am a Iso Manager. My company design and manufacture In vitro medical device.

I have received a supplier letter inform us that they are discontinuing the CE marking of their products because they are now solely a contract manufacturing company. My supplier manufacture in vitro medical devices too.

Somebody could say me What does contract manufacturing company mean?

Thank you

Alberto:thanx:
 
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DannyK

Trusted Information Resource
#2
Re: Contract Manufacturing Company

A contract manufacturer is a company that offers its manufacturing services to companies for a fee. The contract manufacturer will provide its services to many clients.
 

CarolX

Super Moderator
Super Moderator
#3
Re: Contract Manufacturing Company

To add to DannyK's post - a contract manufacture supplies parts and services to OEMs (original equipment manufacture).
 

invitro_spain

Involved In Discussions
#4
Re: Contract Manufacturing Company

Thank you for your information!

A contract Manufacturing company has to meet Medical devices requirements? I think so. I do not understand Why my supplier use this cause to stop selling CE marking products! Do you understand the reason?

Alberto

:thanks:
 
M

MIREGMGR

#5
It costs money to maintain a full quality system, certifications and the like. By becoming a contract manufacturer, they of course lose all of their specification-developer-only customers, who have been relying on the manufacturing company's QMS and certifications. They however presumably retain those of their customers who have their own quality systems and certifications, and haven't been relying on the manufacturer's capabilities in those regards anyway. Presumably they've determined that it's business-preferable to lose the expenses and hassles of maintaining the QMS and certifications.

If you are in the former group, you need a new supplier. If you're in the latter group, you need to review your procedures for control of your supplier to assure that your own systems are adequate to the task of managing a relationship with a supplier that may not maintain a full quality system.
 
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