OUR ONSITE TEST LAB ENABLES US TO DELIVER FAST RESULTS ON STANDARD AND CUSTOMIZED TESTS.
The components and devices we manufacture must stand up to unrelenting physical, biological and chemical forces. To help our customers deliver products that provide long-term efficacy, our in-house test lab team provides a full array of standard and proprietary testing methods.
As with all areas of our company, our test lab professionals employ the latest technology, stay abreast of emerging advances and apply their innovative skills to develop or improve test methods. We adhere to rigorous test standards that meet or exceed FDA, ASTM, CE and ISO criteria. We can also develop test methods to address unanswered questions.
Our test lab team works closely with the project team and with customers to provide standard or customized tests that deliver data that informs the development process. Ready access to onsite testing keeps projects moving quickly and along the right path. Ongoing testing during prototype, clinical and serial production plays a critical role in assuring quality.
TESTING CATEGORIES INCLUDE THE FOLLOWING:
Our experience working in the medical device industry means that you can have confidence in our ability to carefully document test protocols and findings to provide evidence of product performance.
Finite element analysis (FEA) based on real data
Tensile and microtensile testing
Radial-force and crush-force testing
Af temperature testing (BFR, DSC)
Scanning electron microscope (SEM) investigation
Energy-dispersive X-ray spectroscopy (EDX)
Metallography: Grain size, inclusion size and distribution, heat-affected zone (HAZ) analysis
Auger electron spectroscopy (AES)
Leider gibt es für diesen Aussteller kein deutsches Firmenprofil.
TWO SITES, ONE PHILOSOPHY – IDEAS, EXPERTISE AND PASSION.
As a customer-centered company, we view ourselves as an extension of your team. That means we keep your best interests in mind at every turn so that we − and you − feel confident that every project we undertake together achieves optimal success.
The collaborative spirit of our in-house engineers, scientists, materials experts and quality staff plays a vital role in every project. Working with you closely allows us to align your product timelines and clinical milestones to the necessary process design controls. We also keep our eyes on manufacturability to ensure that each component is engineered for quality, reliability and cost-effective manufacturing.
As the world’s foremost manufacturer of finished nitinol self-expandable components to the medical device industry, we offer everything needed to take your idea from infancy through full-scale production. In addition to our consultative approach to design for manufacturability, you benefit from our:
Industry-leading Rapid Response prototyping Center that turns concepts into prototypes within days.
Large and experienced team of engineers, scientists and process experts who provide insight and guidance at every development phase.
Full-service in-house test lab staffed by materials scientists and analysts who help you choose the best materials for your product and help verify and document material integrity.
Lean manufacturing experts who assure competitive commercial production.
Comprehensive array of micromanufacturing and microassembly technologies.
Stable, long-term relationships with top-quality nitinol suppliers and other material vendors.
Quality system that both complies with the FDA’s Quality System Regulation and ISO 13485 and goes beyond compliance to help your project achieve its milestones.
Long-term employee tenure and a very low turnover rate, which provides stability and continuity to our customers.
Ongoing investments in people and technology that keep us at the leading edge of innovation.
German and U.S. facilities that provide business redundancy and convenience