Device History Record. The Supplier and Purchaser will maintain the following portions of the Device History Record required by 21 CFR §820.181. Supplier shall keep records of these activities and make them available to the Purchaser within one business day of request.
Device History Record. Manufacturer shall create and maintain the device history record and make it available to Hyperfine upon request.
Device History Record. The Supplier and Customer will agree on which party maintains selected portions of the Device History Record required by 21 CFR §820.181. This list also includes installation reports (21 CFR §820.170) and servicing reports (21 CFR §820.200). • Record Applicable Supplier Customer Specific Records • Device specifications • Production process specifications • Quality assurance procedures and specifications • Labeling specifications • Packaging specifications • Installation procedures and methods • Installation records • Maintenance procedures, methods, and Records • Servicing procedures, methods, and records Upon the request of the Customer, the Supplier shall make all records available within two working days.
Device History Record. ZIEN will be responsible for maintaining the Device History Records (OHR) as required by FDA 21 CFR 820.184. ZIEN will provide a Certificate of Conformance for each lot of product released for commercial sale. ZIEN will also maintain the complete Design History File and Risk Management File. Device Record Responsibility Record Applicable ZIEN CPI Device master record X X Device specifications X X X Production process specifications X X Quality assurance procedures and specifications X X Labeling specifications X X Packaging specifications X X Maintenance procedures and methods X X Maintenance records X X Design control records X X Risk management file and records X X Upon the request of CPI, ZIEN shall make all records available within two (2) working days.
Device History Record. Supplier shall create and maintain the device history record and make it available to Customer, upon request.
Device History Record. (BATCH RECORD) (DHR) means the complete written record of the history of the batch or lot of a finished device and its production and testing thereof as required under HEALTH AUTHORITY regulations or requirements and in accordance with the DEVICE MASTER RECORD.
Device History Record. 4.04 TriVirix shall present these quality records to Company for immediate inspection by Company on completion of the production cycle, and prior to release of Product into storage per paragraph 2.05. Upon receipt of said records, Company shall perform an immediate inspection of these quality records, and shall within two (2) business days, provide written inspection status (Pass/Reject) to by fax TriVirix. TriVirix shall maintain these quality records for a period of seven (7) years after the last date of manufacture for a Product, or as prescribed by applicable medical device regulations, whichever is longer unless otherwise agreed to in writing by both Parties. Within fifteen (15) days after delivery of Products into storage per paragraph 2.05, Company shall have the right to conduct its product audit to include a physical inspection of Products delivered thereof in which Products will be compared with the specifications and quality control parameters contained in the Quality Assurance Plan and DMR, and shall inform TriVirix of the results of such inspection. In the event such inspection by Company reveals unacceptable variances from the specifications and quality control parameters contained in the Quality Assurance Plan and DMR, Company shall notify TriVirix (which notice shall specify the manner in which the defective Products fail to meet the specifications in the DMR), and TriVirix shall have fifteen (15) days in which to verify the variances. Upon the earlier of (a) verification by TriVirix or (b) the expiration of thirty (30) days from the date of said notice, Company shall have the right to refuse acceptance of the defective or deficient shipment(s) and to require, at the option of TriVirix, that said Products be replaced or corrected free of charge to the Company. If TriVirix's inspection results in a finding that the Products are not defective or deficient, TriVirix shall immediately notify Company of the same and shall resubmit the Products for acceptance. In the event that TriVirix and Company do not agree on the acceptability of a Product, both parties agree to conduct joint testing and/or inspection. Failure of Company to complete the above-mentioned acceptance inspection within said fifteen (15) day period shall constitute acceptance by Company of the Products, however such acceptance shall not reduce the Warranty coverage for Products provided in accordance with Article VII herein.
Device History Record. The Manufacturing Agreement will also provide for Cyberkinetics to perform or cause to be performed quality assurance and control tests on each Collaboration Product and to provide a device history record setting forth for each Collaboration Product delivered the items tested, specifications and results in a device history record containing the types of information which shall have been approved by the Program Management Team or required by the FDA. Cyberkinetics shall maintain (or shall cause the Third Party manufacturer to maintain) all manufacturing records for a period of not less than five (5) years from the date of manufacture and for so long as required under applicable requirements of the FDA.
Device History Record. Manufacturer shall create and maintain the device history record and make it available to Butterfly upon request.
Device History Record. UMM shall present these quality records to Company for immediate inspection by Company on completion of the production cycle, and prior to release of Product into storage per paragraph 2.05. Upon receipt of said records, Company shall perform an immediate inspection of these quality records, and shall within two (2) business days, provide written inspection status (Pass/Reject) to by fax UMM. UMM shall maintain these quality records for a period of time equivalent to each Product's life cycle, plus five (5) years, or as prescribed by applicable medical device regulations, whichever is longer.
