TUV America is authorized by the FDA to submit 510(k) applications on behalf of medical device manufacturers for all eligible Class I & II devices and to provide Third-Party FDA Inspections. In addition to helping with US market regulations, TUV can provide market access to Europe, Canada and Japan, offering manufacturers a single-source solution to their regulatory needs. (read more)

Accutek has extensive experience in a wide variety of medical implant testing. Accutek regularly performs static and dynamic testing for 510(k) submittals to successfully expedite products to market. Accutek's metallurgical experience and metallographic capabilities give our customers added value by providing immediate results for failure evaluations and product enhancements. (read more)

Accutek has extensive experience in a wide variety of medical implant testing. Accutek regularly performs static and dynamic testing for 510(k) submittals to successfully expedite products to market. Accutek's metallurgical experience and metallographic capabilities give our customers added value by providing immediate results for failure evaluations and product enhancements. (read more)

Zwick offers an option for its testing software testXpert® which meets the requirements of FDA 21 CFR Part 11, mainly needed in the pharmaceutical and medical engineering industries. (read more)

Test-Um's NT955 Validator-NT™ is an all-in-one network management tool with a 4-inch color LCD screen. If you're using more than one tool to certify, identify, configure and document your Ethernet network, that's too many! Now just one easy-to-use Test-Um tool will do it all. The Validator-NT provides everything you need to test, trace and tune your Ethernet network. (read more)

Atlas indoor exposure laboratories offer artificial accelerated weathering tests and a variety of other environmental test programs, all designed to accurately simulate true end-use conditions. A fully equipped laboratory for optical property and physical evaluation using the leading measurement instrumentation technology available provides a complete testing progr (read more)

When performing the Product Feasibility Step, or medical material compatibility for FDA Compliance have Associated Polymer Labs check the materials selection. This step can make the difference between a successful product launch and canceling the project after years of hard work. (read more)

If your product calls for high quality , complex shapes, or fast turn-around, call the supplier with a National reputation: National Rubber Corporation. (read more)

Accutek's experience in mechanical testing and weld/braze qualification enable a unique perspective to perform failure analysis on a variety of products and processes. Whether our clients need to compare "good" vs. "bad" or understand "why does this screw keep breaking?" Accutek can support your requirements (read more)

Our exclusive, computer controlled fatigue machines are an ideal solution for your failure analysis or endurance strength determinations. Our PID loop's specified load and frequency provide a continuous real time sampling rate for accurate results. Our evaluation procedure allows clients to participate in the discovery process in a timely manner, while controlling investigation costs. (read more)