Device Master Record – Content

Each device master record and quality system record contain many documents, an index of each is usually needed.

Device Specification

A device or product specification is a specific document in the device master record that briefly describes and gives all important details of the external characteristics of a device. The product specification may also contain some internal characteristics of the device that are important to the manufacturer and/or the users.

Generally a product specification will contain the device's:

• product trade and common name(s);
• intended use(s);
• performance characteristics and theory of operation;
• regulatory classification;
• physical characteristics;
• environmental limitations and product stability;
• important components and formula (if applicable); and
• user safety characteristics.

In addition to defining and describing a device, a product specification is a communication tool which, if used in a timely manner, can help achieve some important results. First, it helps assure that everyone is talking about the same device and working toward the same objectives with respect to safety, effectiveness, human factors, configuration, labeling, packaging, processing, finished device acceptance, etc.

Specific Documents

Specific documents are drawings, procedures, labels, data forms, etc., for a specific product or family of products. Product specific documents are almost always part of the device master record. The originals of specific documents are usually located in files in engineering or technical service departments. In most manufacturers, specific documents contain no general information; however, they often refer to general documents.

Records for In Vitro Diagnostic Products

The main differences between device master records for chemical¬ based in vitro products and for electromechanical products, such as instruments and artificial kidneys, are terminology and the relatively extensive use of written processing procedures and status reports for in vitro diagnostic products rather than a few assembly drawings and test/inspection reports.