Design History File Sample Clauses

Design History File. A new electronic DHF will be created by Cordis for the 18 new Carotid Stent Delivery System catalogs - 65cm length project to allow for development and release of new documentation for these codes.
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Design History File. Mxxxx shall maintain a DHF for the Product(s), which shall contain or reference the Records necessary to demonstrate that the design was developed in accordance with the design plan, the applicable Quality System requirements, and this Quality Agreement. Mxxxx shall own the Product’s DHF and it shall reside with Mxxxx for 3 years, after which time it may be transferred to a document retention site. Mxxxx shall have the ability to obtain access to the DHF within twenty-four (24) hours.
Design History File. Medron, Wortley and King will cooperate with AngioDynamics concerning completion of design, development, Design History File, process validation of processes performed by Medron, and regulatory approvals (including US FDA 510(k) submission and international regulatory approvals).
Design History File. The Parent shall have received, in form and substance reasonably acceptable to the Parent, the complete design history file for the thin-film silver dressing.
Design History File. MAKO Surgical will maintain the EPIK Design History File (“DHF”) including the Product Specification.
Design History File. SeaMED will not create a Design History File for this project. The responsibility for creating and maintaining a Design History File lies with Xxxx. Xxxx maintains the DHF for the system design. Any design changes at SeaMED will be processed through Document Change Notices per SeaMED Document Change Procedure, document 900319. All design related material will be filed in the Design History File by Xxxx. The Design History File will be maintained by Xxxx throughout the manufacturing phase.

Related to Design History File

  • Research Records Each Party shall maintain records of each Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Research Program. All laboratory notebooks shall be maintained for no less than [***].

  • Database File The Servicer will provide the Successor Servicer with a magnetic tape (in a format reasonably acceptable to the Indenture Trustee and the Servicer) containing the database file for each Contract (i) as of the Initial Cutoff Date, (ii) the Subsequent Cutoff Date, (iii) thereafter, as of the last day of the preceding Due Period on each Determination Date prior to a Service Transfer and (iv) on and as of the Business Day before the actual commencement of servicing functions by the Successor Servicer following the occurrence of a Service Transfer.

  • Deliverables Upon completion of each Test for each Reviewable Receivable, the Asset Representations Reviewer shall record a finding based on the issues discovered. Findings categories are listed as follows: • Evidence that the applicable Test was satisfied (“Satisfied Test”); • Evidence that the applicable Test was not satisfied (“Unsatisfied Test”); and • Test incomplete as a result of missing or insufficient documentation (“Unsatisfied Test – Missing Required Documents”).

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

  • Review of Documentation The Depositor, by execution and delivery hereof, acknowledges receipt of the Mortgage Files pertaining to the Mortgage Loans listed on the Mortgage Loan Schedule, subject to review thereof by Xxxxx Fargo Bank National Association, LaSalle Bank National Association, Deutsche Bank National Trust Company and U.S. Bank National Association as applicable (each, a “Custodian” and, together, the “Custodians”), for the Depositor. Each Custodian is required to review, within 45 days following the Closing Date, each applicable Mortgage File. If in the course of such review the related Custodian identifies any Material Defect, the Seller shall be obligated to cure such Material Defect or to repurchase the related Mortgage Loan from the Depositor (or, at the direction of and on behalf of the Depositor, from the Trust Fund), or to substitute a Qualifying Substitute Mortgage Loan therefor, in each case to the same extent and in the same manner as the Depositor is obligated to the Trustee and the Trust Fund under Section 2.02(c) of the Trust Agreement.

  • Maintenance of Review Materials It will maintain copies of any Review Materials, Review Reports and other documents relating to a Review, including internal correspondence and work papers, for a period of at least two years after any termination of this Agreement.

  • Technical Documentation Subject to the terms of this Agreement, BROCADE hereby grants to McDATA a nonexclusive, nontransferable, worldwide license to reproduce and use BROCADE's technical documentation provided to McDATA by BROCADE hereunder, solely for McDATA's internal purposes in connection with the manufacture, marketing and support of the McDATA Products into which the Products are incorporated as set forth herein. Modifications to such technical documentation by McDATA shall require BROCADE's prior written authorization, which authorization will not be unreasonably withheld.

  • Training Materials Training Materials will be provided for each student. Training Materials may be used only for either (i) the individual student’s reference during Boeing provided training and for review thereafter or (ii) Customer’s provision of training to individuals directly employed by the Customer.

  • Technical Specifications Each Bloom System is an integrated system comprised of a fuel cell stack assembly and associated balance of plant components that converts a fuel into electricity using electrochemical means that (i) has a Nameplate Capacity of at least 0.5 kilowatts of electricity using an electrochemical process and (ii) has an electricity-only generation efficiency greater than thirty percent (30%).

  • Product Documentation Supplier shall produce and deliver to Sony Ericsson Product Documentation fulfilling the requirements set out in templates included in Enclosure 2.3.

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