GMP Requirements for Devices

By virtue of the broad diversity of products covered under the medical devices umbrella, GMP regulations and standards for devices tend to be less specific than their drug GMP counterparts. However, it is expected that the manufacturer will use risk analysis to identify specific measures that are appropriate to the manufacturing process under consideration. In effect, this means that many of the GM P measures applicable to drugs will also apply to devices. For example, if a manufacturer is 

1 General requirements - Implement and maintain a quality system 

2 Documentation requirements - Create quality policy, quality manual, procedures, and document control and distribution function. Retain records for the expected lifetime of the device or a minimum of 2 years 

1 Management commitment - Show evidence of top management commitment to quality 

2 Customer focus - Determine and satisfy customer requirements 

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The FDA also use a systems approach when auditing device manufacturing sites. This breaks down the GMP requirements for devices into seven primary subsystems consisting of ... 

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