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Hi Djbeatsent,
Taking a step back from the daily quality issues you contend with can I ask some questions to clarify your status in the mix.
1 - Are you a tooling manufacturing (mechanical engineering) company?
2 - or other ?
3 - Is this medical device 'your product' / did you design it?
4 - are you the Medical Device 'Manufacturer'?
If you are a tool maker for another company who are the medical device manufacturers, I'm finding that No, you dont need 13485. Your client (the medical device manufacturer) may require you to be 9001 approved more than likely, but thats it, end of.
Unless, the answers above say different.
Maybe you can clarify the above position in this scenario and that perhaps would assist you in getting clear and concise feedback and advice.
Xio
Taking a step back from the daily quality issues you contend with can I ask some questions to clarify your status in the mix.
1 - Are you a tooling manufacturing (mechanical engineering) company?
2 - or other ?
3 - Is this medical device 'your product' / did you design it?
4 - are you the Medical Device 'Manufacturer'?
If you are a tool maker for another company who are the medical device manufacturers, I'm finding that No, you dont need 13485. Your client (the medical device manufacturer) may require you to be 9001 approved more than likely, but thats it, end of.
Unless, the answers above say different.
Maybe you can clarify the above position in this scenario and that perhaps would assist you in getting clear and concise feedback and advice.
Xio
3. The medical product is someone's patent. This someone started his own company and went to a bunch of different manufacturers to see who could make his product. The product is basically a plastic piece with electronics in it. We are going to make the mold (excluded from ISO), make the plastic pieces, assemble the electronics (that we receive from electronic manufacturer) into the plastic pieces, and then bulk ship them to the guy who owns the patent. He will then final package it and sell it to a large, well known company to sell it on the shelves of Wal-Mart, Target, etc. Our main design guy was offered the chance to patent the plastic design that he created, but he turned it down. Now the guy with the medical device patent also owns the design of the plastic components.
4. This I am not sure of. Where could documentation of this be found?
