Device Master Record Sample Clauses
The Device Master Record (DMR) clause defines the requirement for maintaining a comprehensive compilation of all instructions, drawings, procedures, and records necessary to manufacture a medical device. This clause typically applies to manufacturers and specifies that they must document and control the specifications, production processes, quality assurance procedures, and packaging methods for each device type. By mandating the creation and upkeep of a DMR, the clause ensures consistency in device production, facilitates regulatory compliance, and helps prevent errors or omissions in the manufacturing process.
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Device Master Record. As used herein, “Device Master Record” shall mean the compilation of the records containing the procedures and specifications for a Production Instrument.
Device Master Record. (a) INHALE shall establish, and may amend from time to time in writing, the DMR for the Devices, Base Units, Transjectors and ▇▇▇▇▇▇▇▇. Each CM shall manufacture the Devices, Base Units, Transjectors and ▇▇▇▇▇▇▇▇ according to the then current DMR, and each CM shall periodically report to INHALE on its performance. The Parties acknowledge that there may be [**], and that [**] Each CM shall agree to any changes in the DMR so long as they (a) are required by the Regulatory Approvals or the Applicable Regulations or (b) are compatible with the scope of such CM's overall business, and if not, the Parties shall discuss such changes to the DMR in good faith. INHALE shall allow the CMs a commercially reasonable period of time to implement changes to the DMR. The CMs agree to implement such changes in an expeditious and commercially prudent manner. [**] [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. [**] Any changes to the DMR shall also be subject to the change control procedure set forth in Section 3.9.
(b) INHALE acknowledges that the DMR is generated by INHALE and transferred to each CM, [**] a Device, Base Unit, Transjector or Chamber that does not conform to the DMR, it shall promptly notify INHALE thereof and shall cooperate with INHALE in trying to resolve such issue.
Device Master Record. NOVA will maintain the DMR and all associated documentation in compliance with FDA QSR requirements and ISO 13485 standards, and shall make the DMR available (including electronic copies thereof) to Cerus on request. All changes to the DMR will be controlled by NOVA’s change request procedures and Cerus will be on the required approval list.
Device Master Record. Supplier shall maintain working drawings for manufacturing and testing the Products, including without limitation, drawings and specifications for component parts to be acquired from specified vendors, test and acceptance procedures and criteria, assembly and subassembly specifications, drawings and requirements, costed ▇▇▇▇ of materials, and manufacturing procedures (collectively called the "DMR"). Aastrom shall own the DMR and all other manufacturing information relative to the Products, which shall be considered Aastrom's confidential information under Section 11 hereof.
Device Master Record. Aspect shall be responsible for generating its own Device Master Record for the Aspect Product, except the DSC-XP. Aspect shall maintain traceability at the board level on the DSC-XP. Dixtal shall be responsible for generating the Device Master Record for the assembled DSC-XP. It is understood that the Aspect BIS Module Kit shall be a component of the Dixtal BIS Module. Dixtal shall be responsible for obtaining and maintaining all applicable governmental authorizations and regulatory approvals required to distribute the combination of Aspect and Dixtal products in the Dixtal BIS Module as provided in Section 13.3.
Device Master Record. 11 3.7 PACKAGING SPECIFICATIONS...........................................12 3.8