Design History File definition

Design History File shall have the meaning set forth in Title 21 of the US Code of Federal Regulations, Part 820.
Sample 1Sample 2Sample 3
Design History File means a compilation of records that describes the design history of a finished medical device as required by the FDA pursuant to 21 C.F.R. Part 820, including design input, design output, design review, design verification, design validation, design transfer, and design changes, or the equivalent as required by an FDA Counterpart.
Sample 1Sample 2
Design History File means a compilation of records which describes the design history of a finished device.
Sample 1Sample 2

Examples of Design History File in a sentence

  • The Design History File shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of design and development.

  • Records of the results of the review of changes and any necessary actions shall be maintained.Note.-Each manufacturer shall establish and maintain a Design History File for each type of device.

  • The activities not conducted include: Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, Design Changes, and Design History File.

  • Your firm identified its plan to establish a Design Control procedure according to 21 CFR 820.30, as well as establish a Design History File for products intended for distribution in the U.S. However, until your firm establishes Design Control procedures and a Design History File and provides a copy to the Agency for review, the adequacy of the response cannot be determined.

  • The Design History File did not include clinical risk analysis specific to the intended use of Model 720 design.

  • Design changes are documented and maintained in the Design History File.

  • I think it is important before we talk about Bill 28 that we take a step back and look at the situations Albertans find ourselves in in regard to opioids and addiction.

  • The Design History File is maintained by the design team leader during the development process and then turned in to Document Control for archiving after the project is complete.

  • The requirements are generally maintained in the Design History File (DHF) during the development phase.

  • Traceability that the risk controls are effective is provided through Verification and Validation (V&V) references in the SyncVision System Design History File.


More Definitions of Design History File

Design History File means a compilation of records which describes the design history of a finished device.correspondence which are stored at various physical locations. Quality system plans applicable to a development project may reside in the quality assurance department, while the chief engineer may be responsible for maintaining design and development plans. These diverse records need not be consolidated at a single location. The intent is simply that manufacturers have access to the information when it is needed. If a manufacturer has established procedures for multiple filing systems which together satisfy that intent, there is no need to create additional procedures or records.
Sample 1
Design History File means, with respect to any Product, each of the following (i) design control process and revision, (ii) design and development plan, (iii) user needs / intended uses / design inputs, DCTM (inputs), (iv) design review I meeting minutes and attachments, (v) design outputs, DCTM (outputs), (vi) design review II meeting minutes and attachments, (vii) design verification protocols / reports, (viii) design validation protocols / reports, (ix) design verification / validation, DCTM (complete), (x) design review III meeting minutes and attachments, (xi) additional design review minutes and attachments (if applicable), (xii) final responses to design review observations, (xiii) risk management file, (xiv) usability engineering file, (xv) design transfer activities (specification review and checklist), (xvi) design transfer checklist, (xvii) design closure checklist and (xviii) the information required to be created and/or maintained under the Company’s SOP-01004, as amended from time to time.
Sample 1
Design History File means a file created and maintained by Nova that documents the Product development process.
Sample 1
Design History File means the documentation relating to the Development and pathway to Marketing Authorization Approval for a product, including the following: (a) specifications; (b) requirements specifications; (c) risk management documentation; (d) clinical evaluation; (e) assessment of applied standards; (f) verification and validation documentation; and (g) regulatory (including FDA and Notified Body) certification documentation.
Sample 1
Design History File or “DHF” shall mean the manufacturer’s file that contains documents or references to documents that demonstrate that the design of the device was developed in accordance with the design plan and the requirements identified as design inputs and outputs in the manufacturer’s design control process and applicable regulations.
Sample 1

Related to Design History File

  • APIs means SAP application programming interface and accompanying or related Documentation, source code, tools, executable applications, libraries, subroutines, widgets and other materials made available by SAP or through SAP tools or SAP Software Development Kit (and all derivative works or modifications thereof) to Provider that allow Provider to integrate the Provider Service with the Cloud Service, including any access code, authentication keys or similar mechanisms to enable access of the APIs.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Contractor Software means software which is proprietary to the Contractor, including software which is or will be used by the Contractor for the purposes of providing the Services.

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • Design Documentation means all schematics and test, assembly and package documentation relating to the Product, including all design, specification and assembly documentation and data files for Materials, which is necessary for the production, manufacture, qualification, testing and delivery of the Product to be attached as Exhibit A.

  • Project Record means the separate set of Drawings and Specifications as further set forth in paragraph 4.02A.

  • Sample means urine, blood, breath, saliva, or hair.

  • 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.

  • Deliverables means the work product and other output of the Services required to be delivered by Contractor as part of the Services, as specified in the relevant section of the Contract.

  • IP Materials has the meaning given to it in clause E8.1 (Intellectual Property Rights).

  • Personnel file means, for the purposes of Part III (8VAC20-90-60 et seq.), any and all memoranda, entries or other documents included in the teacher's file as maintained in the central school administration office or in any file regarding the teacher maintained within a school in which the teacher serves.

  • The Works/Project means the works to be executed or done under this contract.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • Background Material means any pre-existing works in which the Intellectual Property Rights are owned by either Party, which have been prepared by that Party outside the scope of this Agreement or which were licensed from a third party by that Party.”

  • 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.

  • Batch Record means the production record pertaining to a Batch.

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • Design Development Documents means the Drawings, Specifications and other documents prepared by the Trade Contractor that establish and describe the size and character of the Trade Contractor Work as to architectural, civil, structural, mechanical and electrical systems, graphics and signage, and other elements, and which include typical construction details, equipment layouts and specifications that identify major materials and systems.

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • Construction materials means any tangible personal property that will be

  • System Software means Software that provides the operating and management instructions for the underlying hardware and other components, and is identified as such in Appendix 4 of the Contract Agreement and such other Software as the parties may agree in writing to be Systems Software. Such System Software includes, but is not restricted to, micro-code embedded in hardware (i.e., “firmware”), operating systems, communications, system and network management, and utility software.

  • Output Material means any Documents or other materials, and any data or other information provided by the Supplier relating to the Specified Service;

  • Client Software means software that allows a Device to access or utilize the services or functionality provided by the Server Software.

  • Data Package has the meaning set forth in Section 2.9(a).