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Devices and Diagnostics Consulting Group Inc.

Devices and Diagnostics Consulting Group, Inc. provides FDA regulatory consulting services to the medical device industry with a focus on in vitro diagnostics (IVDs). Among our capabilities are:

• Development of pre-market submission strategies
• Premarket submission preparation (510(k)s, PMAs, IDEs, reclassification petitions, etc) and reviews
• Assistance in preparing FDA correspondence
• Procedure and user manual development
• Assistance with FDA compliance matters, GMP/QSR reviews, development and auditing (including SOP development and review)
• Good clinical practice auditing
• Clinical protocol development
• Statistical support services
• FDA staff meeting preparation and participation
• FDA Advisory Panel preparation...

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