Device History Record definition

Device History Record or “DHR” means a compilation of Records containing the production history of the Product(s).

Device History Record means a compilation of records containing the production history of the Product(s).

Device History Record shall have the meaning ascribed in 21 CFR 820.

Examples of Device History Record in a sentence

• Supplier maintains a Device History Record (DHR) for the manufacturing and quality documentation of each lot/batch produced.

• Client shall visually inspect Product upon receipt for abusive handling, inadequate packaging, or other damage which may occur in shipping and review BIT’s Certificate of Conformance and Device History Record prior to accepting Product.

• Diametrics assures the access of DHR (Device History Record), DHT (Device History Traveler), and DMR (Device Master Record) in support of Philip's timely answering of Portal Measurement Product questions from the FDA.

• If a product is allowed to be released under concession or is reworked, this should be recorded in the Device History Record (see 4.16).

• Such files can be referred to as Device History Record, Batch Manufacturing Record, Lot History Record or Lot Record.

More Definitions of Device History Record

Device History Record shall have the meaning ascribed to it by the regulations of the FDA, as may be amended or changed from time to time.

Device History Record means the compilation of records of production history that are maintained for each batch, lot or unit to demonstrate that a medical device is Manufactured in accordance with the Device Master Record and the requirements therein, as required by the FDA pursuant to 21 C.F.R. Part 820, or the equivalent as required by an FDA Counterpart.

Device History Record means a compilation of records in accordance with cGMPs containing the production history of finished Products.

Device History Record. The actual production records for a particular device that shows the processes, tests, and rework used to produce a device. Includes component(s) used, manufacturing (assembly and packaging) procedures, inspection and test results, device labelling, and any other documentation required to produce the components and/or subassemblies. DEVICE MASTER RECORD: The master listing of all procedures, specifications, and bills of material, which are required to produce a product. DESIGN VALIDATION: Establishing by objective evidence that device specifications conform to user needs and intended use(s).

Device History Record. ("OHR") means a compilation of records containing the production history of the Business Partner Product(s). ​ ·Device Master Record"("DMR") means a compilation of records containing the procedures and specifications for the Business Partner Product(s). ​

Device History Record has the meaning set forth in 21 C.F.R. 820.3(i).

Device History Record means DePuy’s compilation of documents created for each lot of each component manufactured (i.e., cup, liner, and head) that tracks the lot from the time of manufacture through the point at which it is ready for sale.