Pharmaceutical, Medtech and cosmetics PLM, PPM & Go To Market platform

PLATFLOW

PLM device master record (DMR)

A PLM (Product Lifecycle Management) device master record (DMR) is a document or set of documents that contains all the information necessary to manufacture, distribute, and use a specific medical device or other regulated product. This information can include information such as the device's design, specifications, testing procedures, and instructions for use, as well as any other relevant information about the device, such as its intended use, any potential risks associated with its use, and the results of any testing or inspections performed on the device.

A DMR 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 DMRs for each device that they manufacture.

In addition to being used for regulatory compliance, DMRs 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 master record (DMR) is a document or set of documents that contains all the information necessary to manufacture, distribute, and use a specific medical device or other regulated product, such as the device's design, specifications, testing procedures, and instructions for use, as well as any other relevant information about the device, such as its intended use, any potential risks associated with its use, and the results of any testing or inspections performed on the device. 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.

Write us on Whatsapp