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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Getting Started

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It is essential that the firm establishes and maintains a quality system that is appropriate for the specific medical device being manufactured and meets the requirements of the Quality System Regulation. The Management Representative has the responsibility to ensure that the requirements of the Quality System Regulation have been effectively established and maintained. Prior to your review of any subsystem, interview the Management Representative (or designee). The objective of this interview is to obtain an overall view of the subsystem as well as a feel for management's knowledge and understanding of the subsystem.

An important linkage for this activity is Management Controls (820.20 Management Responsibility).