Design Validation definition

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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Examples of Design Validation in a sentence

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

  • With respect to the Disinfectors, the Company shall conduct Verification, Design Validation, and Process Validation activities to ensure the performance of the Disinfector, including but not limited to the ability of the Disinfector to perform high-level disinfection and/or sterilization of the Equipment and to safely remove all residual cleaning and disinfecting materials and sterilizing agents from the Equipment.

  • Design Validation shall ensure that the Product(s) conforms to defined user needs and intended uses, and shall include testing of the Product(s) under actual or simulated use conditions.

  • Due to the fact the this Prototype Phase is not being performed, the Critical Design Review will be held during the Design Validation phase.

  • In the building of the Design Validation units and Process Validation units, MMICs will be pulled from a collection of various engineering lots and production lots.

  • Any such Engineering Change Request during the project after Design Validation and/or Manufacturing Process Validation or any part thereof shall be brought forward to the Nokia Project Manager.

  • Such documentation shall include, without limitation, specifications, performance testing, Verification protocols and test results, Design Validation protocols and test results, and Process Validation protocols and test results.

  • Supplier is responsible for conducting and documenting a complete Design Validation Test ("DVT").

  • Within 30 days after the date of this Agreement, each of OAI and the Company shall identify for the other, in writing, its primary personnel contacts regarding communication of testing, Verification, Design Validation, and Process Validation issues.

  • The Seller shall communicate all design and process changes as they deviate from either DV (Design Validation) or PV (Process Validation) as described in the Nokia Design and Process Change Management Requirements For Microwave Module Suppliers.

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 intentional and unauthorized falsification or invention of any information or citation.

  • 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.