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The announcement follows the successful completion of a five-day audit of the medical facility, in which FDA inspectors conducted an evaluation of the facility's internal quality system, including compliance to FDA quality system regulations. The benefits of registration to ISO 13485 include international recognition of compliance with the FDA Quality System Regulations and unique medical industry standards, facilitation of global business, and improvement of process, product, and service quality. Camstar's InSite Medical Device Edition helps medical device and diagnostics manufacturers increase manufacturing yields, improve quality, and more easily comply with the FDA's Quality System Regulations. |
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