Contract Manufacturer Offers Regulatory Submission Program

January 28, 2009

1 Min Read
Contract Manufacturer Offers Regulatory Submission Program



Contract manufacturer BC Tech, which specializes in Class I, II, and II devices, now offers a regulatory submission program.

Product development and contract manufacturing services provider BC Tech (Santa Cruz, CA) has expanded on its current capabilities to offer a regulatory submission program. Designed to make the most of quality assurance measures already in place, the program runs parallel to the company's development and manufacturing processes to anticipate regulatory milestones so that products can be properly submitted and then approved. This format is supposed to help reduce regulatory costs and time to market, according to the company. The program includes assistance with FDA 510(k) and PMA submissions, investigational device exemption applications, and relevant product safety certifications. In addition to risk analysis, the company offers documentation for design controls, prototyping, verification procedures, and manufacturing operations. Experienced in producing Class I, II, and III devices, the company employs manufacturing groups that specialize in mechanical engineering, industrial design, electronics, software, and bioresearch.

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