II-VI Marlow is proud and excited to announce the recent ISO 13485 certification of our state-of-the-art manufacturing facility in Vietnam. This certification was granted by Bureau Veritas, a world leader in testing, inspection, and certification services (TIC).
With the recent ISO 13485 certification, we can fully support low cost, high volume manufacturing for FDA compliant medical assemblies. This allows us to meet and exceed the needs of our customers.
The ISO 13485 certifications of the Dallas design center and Vietnam manufacturing facility gives our customers an outstanding combination of experienced engineering design and high volume manufacturing. “With these capabilities, we can better serve our customers with complete design and manufacturing solutions for FDA compliant medical applications”, states II-VI Marlow’s General Manager Kevin MacGibbon.
Rapid advances in the biomedical field are driving the growing demand for specialized equipment from adequately certified design centers and factories. This certification is a part of II-VI’s strategy to leverage our thermal management and mechanical design expertise to provide FDA approved biomedical assemblies and equipment to customers. We provide product development of the highest quality by conducting extensive performance and reliability tests, including mechanical integrity and endurance tests.
II-VI will leverage its broad portfolio of materials, components and subsystems to manufacture a wide range of biomedical systems including PCR systems, blood analyzers, reagent chillers, injury treatments systems and dental systems. II-VI’s thermal engines can include thermoelectric modules, cold plates, heat sinks, thermal interface materials, sensors and fans.
We are anxious to continue moving forward in the realm of biomedical assemblies and exceed the needs of our customers. You can explore all of our thermoelectric coolers, generators, and systems here.
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