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Eclipse Produce Development announces that it has expanded its product development facility to provide small-run pilot production services by adding 2,000 sq ft of space.
In building out the facility, President Jim Sellers recognized that many medical device clients seek part runs in the 100's or less for clinical trial builds, V&V testing, and assembly line debugging that high-volume contract manufacturing service providers are unlikely to provide cost-effectively. "The facility expansion was completed to meet our goal of providing high-quality short-run product manufacturing and assembly in a dedicated clean environment. "Establishing the new facility," says Sellers, "extends our ability to providing comprehensive product development services." The new assembly facility emphasizes cleanliness, validations, and reliable delivery of assembled products.
Eclipse's product development and pilot manufacturing services fulfill the process controls required for Specification Developers under the Quality System Regulations of Section 21 of the Code of Federal Regulations Part 820 and International Standards Organization 13485/2003. Serving as a Specification Developer, we create elements for Design History Files and Device Master Records following our clients' quality management system standard operating procedures.
About Eclipse:
ECLIPSE PRODUCT DEVELOPMENT is a full-service product design and engineering firm with over 16 years of experience helping clients commercialize their consumer, medical, and industrial product technology. Eclipse has a broad portfolio of products, instruments, disposables, and equipment that users find appealing, useful, and usable. For more information, visit www.eclipsepd.com.
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