Design validation definition

Design validation means estab- lishing by objective evidence that de- vice specifications conform with user needs and intended use(s).
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Design validation means estab- lishing by objective evidence that de- vice specifications conform with user needs and intended use(s). Food and Drug Administration, HHS § 820.25
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Design validation meansestablishing by objective evidence that device specifications conform with user needs and intended use(s).
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Examples of Design validation in a sentence

  • Design validation shall include software validation and risk analysis, where appropriate.

  • Design validation shall ensure that devices conform to defined user needs and in- tended uses and shall include testing of production units under actual or simu- lated use conditions.

  • Design validation shall be per- formed under defined operating condi- tions on initial production units, lots, or batches, or their equivalents.

  • Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.

  • Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

  • Design validation methods should include a hazard analysis and safety risk assessment for ADS, for the object event detection and response (OEDR), but also for the overall vehicle design into which it is being integrated and when applicable, for the broader transportation ecosystem.

  • Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.

  • Design validation for product design services provided by Carlson Tool & Manufacturing Corp.

  • Design validation shall ensure that devices conform to defined user needs and intended uses and includes testing of production units under actual or simulated use conditions.

  • Lartillot O, Eerola T, Toiviainen P, Fornari J (2008) Multi-feature modelling of pulse clarity: Design, validation, and optimization.


More Definitions of Design validation

Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s). (21 C.F.R. Part 820.3(z)(2))
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Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s). §820.3(aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
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Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).
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Related to Design validation

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Design flow means the average annual flow or average daily flow specified in an approved facilities plan or approved plans and specifications, the flow specified in a WPDES permit, or the flow required to meet performance standards.

  • Fabrication means making up data or results and recording or reporting them.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Design storm means a hypothetical discrete rainstorm characterized by a specific duration, temporal distribution, rainfall intensity, return frequency, and total depth of rainfall.

  • Design means the appearance of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself and/or its ornamentation;

  • Application Software means Software formulated to perform specific business or technical functions and interface with the business or technical users of the System and is identified as such in Appendix4 of the Contract Agreement and such other Software as the parties may agree in writing to be Application Software.

  • Design Manual means the MOHLTC design manual or manuals in effect and applicable to the development, upgrade, retrofit, renovation or redevelopment of the Home or Beds subject to this Agreement.

  • Third Party Components means software and interfaces, licensed by RIM from a third party for incorporation into a RIM software product, or for incorporation into firmware in the case of RIM hardware products, and distributed as an integral part of that RIM product under a RIM brand, but shall not include Third Party Software.

  • Design Documentation means all:

  • Design Phase means the period during which the Transporter shall prepare a draft project proposal for publication in accordance with section 4.3;

  • Design-build contract means a single contract with a Design-Build Firm for the design and construction of a public construction project.

  • Service Component means certain enabling Software, hardware peripherals and associated documentation which may be separately provided by Symantec as an incidental part of a Service.

  • Design Standards means the standards developed as a requirement of the Programmatic Agreement

  • Design-build means a project delivery method in which the detailed design and subsequent construction is provided through a single contract with a Design-Build firm; a team, partnership, or legal entity that includes design professionals and a builder. The Design-Build Project delivery shall be implemented in accordance with Tex. Gov’t Code § 2166.2531.2

  • Installation means that the System or a Subsystem as specified in the Contract is ready for Commissioning as provided in GCC Clause 26 (Installation).

  • Runtime Product means the version specific files and application program interfaces (APIs) specified in the RUNTIME.TXT file provided with SAP Crystal Reports 2008, SAP Crystal Reports for Eclipse 2.0, and SAP Crystal Reports for Visual Studio 2010.

  • Manufacturing Process means any process for—

  • Customization means any customer-specific modification to software that requires changes to the software’s source code.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Specifications means the Specifications of the Works included in the Contract and any modification or addition made or approved by the Project Manager.

  • Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

  • Acceptance Testing mean the tests, reviews and other activities that are performed by or on behalf of Agency to determine whether the Deliverables meet the Acceptance Criteria or otherwise satisfy the Agency, as determined by the Agency in its sole discretion.

  • refurbishment means repairing of used electrical and electronic equipment as listed in Schedule I for extending its working life for its originally intended use and selling the same in the market or returning to owner;

  • Retrofit means to alter, improve, modify, remodel or renovate a building, facility or structure to make that building, facility or structure more energy-efficient.