Design History File definition

Design History File means a compilation of records which describes the design history of a finished device.

Design History File shall have the meaning set forth in Title 21 of the US Code of Federal Regulations, Part 820.

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.

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.

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

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

• 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.

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

• 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.

• 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.

• 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.

• The TDP shall include all necessary documentation and data for the Government, or its designee, to continue the development or production of the product, including but not limited to the Design History File, Device Master Record, and Device History File.

• Specific training is available for support staff and psycho-pedagogues (Eurydice.

More Definitions of Design History File

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.

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.

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

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.

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.