FDA Approved Assemblies & Facilities

Rapid advances in life sciences are driving the growing demand for specialized equipment from certified design centers and factories. The ISO 13485 certification is a requirement for factories that manufacture FDA approved assemblies.  This stringent quality certification requires detailed design and manufacturing processes that provide customers the assurance of highly uniform manufacturing processes. Our new product introduction (NPI) engineering teams can provide full optical, mechanical and electrical system support from design to volume manufacturing of FDA approved biomedical assemblies.

ISO 13485 Factories: Dallas

II-VI’s ISO 13485 certification at its Dallas site marks the successful implementation of a comprehensive quality management system to support the design and manufacture of medical devices and systems for FDA approved equipment.

II-VI’s broad portfolio of materials, components and subsystems enable a wide range of biomedical equipment including PCR systems, blood analyzers, reagent chillers, as well as injury treatment and dental systems.

II-VI provides optimum thermal management solutions for applications in life sciences, including genetic analysis, immunoassay, pharmaceutical development, clinical diagnostics, food analysis, agricultural development, environmental analysis, industrial hygiene and identification of bio-threats. II-VI’s broad array of thermal management solutions includes precision systems for thermal cycling, temperature stabilization, as well as air and fluid temperature control.