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Plastic Extrusion of Medical Device Components - No ISO or AS 9100 Certifications

Nicole Desouza

Starting to get Involved
#1
Hello All,
I work for a small plastics extrusion company and we have just received word that we will begin production of medical device components. We do not currently have any certifications with ISO, AS 9100 or any governing agency. My question is, Do we need to be certified before we can begin making these parts?

thanks,
Nicole
 

blackholequasar

Starting to get Involved
#3
It may benefit you to undertake ISO but it's certainly not a requirement unless your customer specifies you must comply. I worked with a small metal manufacturer that made medical devices parts (tubes, cutters, etc.) and they were NOT ISO certified. Bigger companies that make medical devices took the risk to buy product from them. It all depends on the quality delivered.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
You must make sure that your "components" can't and won't be considered Medical Devices in their own right when placed on the market (regardless of customer intentions). The exact definition of "Medical Device" depends on the specific market they are placed in (i.e. where you sell them). If they may be considered Medical Devices a whole raft of requirements will apply.
 

Nicole Desouza

Starting to get Involved
#5
You must make sure that your "components" can't and won't be considered Medical Devices in their own right when placed on the market (regardless of customer intentions). The exact definition of "Medical Device" depends on the specific market they are placed in (i.e. where you sell them). If they may be considered Medical Devices a whole raft of requirements will apply.
Hi Ronen,
thanks for your comment. Where can I read the written standards / regulations on this? I need to be able to site something concrete when I am talking to management.
thanks,
Nicole
 
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