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PLM device history record (DHR)

A PLM (Product Lifecycle Management) device history record (DHR) is a document or set of documents that contains detailed information about a specific device or product. This information can include information such as the device's design, manufacturing, testing, and inspection records, as well as any other relevant information about the device, such as its intended use, instructions for use, and any potential risks associated with its use.

A DHR is typically used to support the regulatory compliance of a medical device or other regulated product. It is a legal requirement for manufacturers of medical devices in many countries, including the United States and the European Union, to maintain DHRs for each device that they manufacture.

In addition to being used for regulatory compliance, DHRs can also be used to support quality control, risk management, and product traceability efforts. For example, they can be used to track changes to a device's design over time, or to identify and address any quality issues that may arise during the device's manufacture or use.

In summary, a PLM device history record (DHR) is a document or set of documents that contains detailed information about a specific device or product, such as the device's design, manufacturing, testing, and inspection records, as well as any other relevant information about the device, such as its intended use, instructions for use, and any potential risks associated with its use. They are typically used to support the regulatory compliance of a medical device or other regulated product, and can also be used to support quality control, risk management, and product traceability efforts.

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