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Noblitt & Rueland

5405 Alton Pky., 5A #530
Irvine, CA 92604-3718
Tel: 714/258-4646
Fax: 714/258-3990

E-mail: info@noblitt-rueland.com

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Description:
Provides specialized consulting in design control; risk management and ISO 14971; FDA QSR and ISO 13485 quality systems and auditing; software quality assurance and compliance assessment; software verification, validation, and testing; product and software development; Part 11 electronic recordkeeping and IEC 60601-1. The company authors complete submissions or software sections for 510(k)and CE mark approvals. In addition, it offers general and in-house training seminars.

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