Medical Prototyping
| Spectrum Plastics Group prides itself on being a premier supplier to the medical device community. With ISO 9001:2000 and ISO 13485:2003 certifications, and Class 7 and Class 8 Clean rooms, Spectrum Plastics Group truly is a leading edge partner for your contract manufactured medical device applications. Spectrum Plastics Group can Mold, Assemble, Package, and manage the Sterilization for your products to meet the diverse needs of your program. |
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On the prototype end, we have three prototype solutions specifically for the medical market, allowing you to receive medical grade prototypes directly from your CAD files, some in at little as 1-2 days.
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Laser Sintered Nylon:
Our nylon is USP Class VI certified for biocompatibility, and it also fulfills the requirements for ISO 10993-1 certification. This means that from your CAD files, you can receive real, biocompatible, direct sintered nylon parts, in as little as 1-2 days. For more on the Laser Sintering process, click here. |
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Stereolithography:
The clear WaterShed 11122XC SLA resin is also USP Class VI certified for biocompatibility. This means the Spectrum Plastics Group is able to supply you with rigid clear prototypes directly from your CAD files, again in as little as 1-2 days.
New in October 2009:
"DSM Somos WaterShed® XC 11122 and ProtoGen™ 18420 have passed ISO 10993 biocompatibility testing. This is a major accomplishment, given this ISO test is considered to be more stringent and more widely accepted within the medical device community worldwide than even USP Class VI."
Downloads of interest:
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Cast Polyurethanes:
And finally, we are able to create plastic and rubber-like multiples from your CAD files with cast urethanes that are also fit for medical applications. These "Food & Drug Grade" urethanes all meet USP Class VI certification, and we are able to offer both rigid and elastomeric materials. For more information about the silicone RTV molding process click here, and please contact us if you have a specific application you'd like to discuss.
If you have any questions about any of these materials, or any of our prototype or production methods, please contact us and we will be happy to assist you.
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