Device Master Record definition

Device Master Record means the compilation of records containing the procedures and Specifications for the Product.

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

Device Master Record shall include device specifications, production process specifications, quality assurance procedures and specifications (including acceptance criteria and quality assurance equipment to be used), and packaging and labeling specifications.

Examples of Device Master Record in a sentence

• All controlled documentation, including that which is Supplier-generated, required for the manufacture and testing of the SynCardia Finished Device will be maintained by SynCardia in the Device Master Record (DMR).

• All regulatory filings with the FDA or any other Regulatory Authority relating to the ViewRay system incorporating the Product will be made in the name of ViewRay or its designee and ViewRay will be responsible for maintaining the Device Master Record for such system.

• Copies of the Device Master Record shall be made available to Customer at Customer’s request.

• Customer shall have the right from time to time to request that changes be made to the Device Master Record.

• As used herein, “LSR Production Instruments” are systems, built with all series-level hardware features, manufactured using series-level manufacturing techniques and manufactured under full scope of the Device Master Record after declaration of production readiness.

More Definitions of Device Master Record

Device Master Record for a Product means the information required to manufacture such Product, including the bill of materials (excluding material formulations), tooling, test fixtures, process flow documentation, design files, quality inspections and similar materials. The Device Master Record will not include the formulation of any proprietary materials of Parlex, including any inks, adhesives, coating or other materials, used in the manufacture of the Products.

Device Master Record means the compilation of records that contain the procedures and specifications for a finished medical device, as required by the FDA pursuant to 21 C.F.R. Part 820, including medical device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications and installation, maintenance and servicing procedures and methods, or the equivalent as required by an FDA Counterpart.

Device Master Record means the compilation of records containing the procedures and specifications for the Product.

Device Master Record means the master control record prepared by MTIA and Echo for a medical device which shall include, or refer to the location of, the following information: (a) device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) packaging and labeling specifications, including methods and processes used; and (e) installation, maintenance, and servicing procedures and methods.

Device Master Record or "DMR" means the compilation of the records containing the procedures and specifications for a Device, Base Unit, Transjector and Chamber. The DMR includes, but is not limited to drawings, CAD files, batch records, manufacturing procedures, test protocols and procedures and inspection protocols and procedures. The DMR may be amended from time to time as provided in Section 3.6.

Device Master Record. The term "Device Master Record ("DMR") as used herein shall mean the compilation of records containing the procedures and specifications for a finished device as described by 21 CFR Section 820.3(j) and Section 820.18 1.

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