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FEA for the FDA, and
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As we all know, the search for reliable vendors can be a daunting
task. Finding a test vendor is no exception, given the wide variety of
tests, standards, equipment, and certifications available today. To help
simplify the process, the first step is to weigh contract testing versus
in-house testing. Consider contract testing when:
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A company that developed a new line of intervertebral body-fusion
devices (IBFDs) almost shelved the entire project when confronted with
FDA-testing requirements. The FDA mandates that all companies must test
physical prototypes to ASTM standards before a device earns approval.
The new line consisted of three separate but similar designs for
distinctly different areas of the lumbar region of the spine. It also
had six to eight size variations to better match patient anatomy. With
the tab for physically testing one device coming in at around $50,000,
testing the entire line would cost $1.2 million and make the project
uneconomical.
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Stainless steel is widely used in the food and medical industries
because it is easily cleaned and sanitized. Strength and corrosion
resistance often make it the material of choice in transportation and
processing equipment, engine parts, and firearms. And sometimes,
designers specify stainless simply for its appearance, not for its
structural properties. However, its benefits don’t fit every
application.
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A new version of the Web site amtencoder.com covers the
proprietary AMT modular encoder series, available in OEM quanties online
through Digi-Key Corp. The site features detailed product
pages, technical documents, videos, frequently asked questions, and a
news section. Reportedly, the AMT encoder has a capacitive,
code-generating technology that almost eliminates the old cost vs.
resolution dilemma.
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Engineers at Livengood Engineering used PTC CoCreate software
to design the Livengood Platform, a medical-device cart that holds the
devices patients need while supporting patients so they can walk around.
Any device attached to a patient has a position on the platform,
eliminating the need to attach devices to a bed, wall, and IV pole.
According to the company, the software helped it easily tackle the
unpredictable and frequent design modifications usually encountered
during the design and build of a completely new product. An easy,
out-of-the-box installation let engineers move directly from working
with 2 × 4-ft wooden mock-ups of the product to 3D computer models on
the same day it installed the software.
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The 5606 and 5607 Full Immersion PRTs (platinum resistance
thermometers) from Hart Scientific perform in “full
immersion” applications where the transition junction and the lead
wires must withstand temperatures covering the entire operating range of
the probe. Such applications can include calibration or validation of
sensors used in laboratory or bio freezers, walk-in refrigerators,
autoclaves, ovens, stability test chambers, furnaces, or incubators.
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Fast doesn't mean simple
Proto Labs created The Protomold Torus to demonstrate interesting,
complex features that can be designed into your parts for an assortment
of different purposes. "The Torus" comes with an informational user key
that describes the features and mold-making techniques used to produce
those features.
Request one today!
Boker’s 2010 Washer Catalog
Boker's free 2010 Washer Catalog features over 24,000 non-standard flat
washer sizes with ODs of 0.080" to 5.140"; numerous IDs and thicknesses;
2,000 materials; and no tooling charges. ISO 9001:2008 Registered.
www.bokers.com/mee
Prototyping White Paper
Whether you're a newbie, expert or in-between, our Prototyping Processes
white paper will help you choose the best process for your project. It's
packed full of excellent info on strength, finish, material properties,
and more. Register for free white paper download.
Phillips Plastics Corporation®
Medical OEM projects often require more that a custom part or a vendor
with limited services. Learn more about the engineering services,
materials support, clean rooms, quality control, packaging,
sterilization, manufacturing technologies available from Phillips Plastics.
Product & Material Testing
Medical OEMs are product and technology experts, but understanding test
requirements and carrying them out is challenging, taking you away from
what you do best. Learn more about medical product test methods and
requirements from the experts at DDL. www.testedandproven.com
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