Design History File definition

Design History File means a compilation of records which describes the design history of a finished device.
View Source
Design History File shall have the meaning set forth in Title 21 of the US Code of Federal Regulations, Part 820.
View Source
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.
View Source

Examples of Design History File in a sentence

  • SynCardia will maintain a Design History File (DHF) during product development.

  • Copies of relevant Design History File documentation will be provided to CM upon project commencement.

  • Supplier shall update the Design History File and Device Master Record, as applicable, and provide copies of such documentation to SI-BONE upon implementation of the Optional Improvement.

  • MFR will maintain the Design History File and all associated documents (input, output, design FMEA, verification, and validation).

  • Supplier shall provide Distributor upon request with copies of such records free of charge, in cases (a) necessary for Distributor to execute its obligations under the Distributor Agreement and (b) in a timely manner, if required by applicable laws or regulations Supplier shall establish and maintain a Design History File (“DHF”), as described in article 17, for each type of Product.

  • SI-BONE shall update the Design History File and Device Master Record, as applicable, and provide copies of such documentation to SI-BONE upon implementation of the Required Improvement.

  • The Design History File shall be kept by Seller for two (2) years after Seller's last production date of the Product.

  • Manufacturer shall allow Distributor to audit the Design History File or any related design documentation as available (including design controls), as well as any validations required pursuant to the Quality System Regulations.

  • NRE activities may include but are not limited to: internal costs for engineering efforts to transfer/supplement the Design History File and Device Master Record, external efforts associated to Circuit Card Assembly set-up and test processes/fixtures.

  • The results of design reviews shall be documented in the Design History File (DHF).


More Definitions of Design History File

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.
View Source
Design History File means a file created and maintained by Nova that documents the Product development process.
View Source
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.
View Source
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.
View Source

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.

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

  • Sample means a sample of blood, tissue or other biological material.