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Chris Flahive Associates

P.O. Box 63
Belle Mead, NJ 08502
Tel: 908/281-7000
Fax: 908/281-7245

E-mail: flahive@ix.netcom.com

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Description:
Offers FDA and EC quality system consulting to the medical device industry, including in vitro diagnostics, in the assessment, design, development, and implementation of quality systems. The firm specializes in compliance solutions, quality system documentation, auditing, ISO 9000/EN 46000/MDD registration preparation and preassessments, supplier/service quality, design control, on-site training in FDA/ISO/EN quality systems, EC directives, validation, and sterilization technology.

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