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.
a. Device specifications (Purchaser)
b. Production process specifications (Supplier)
c. Quality assurance procedures and specifications (Supplier)
d. Labeling specifications (Purchaser)
e. Packaging specifications (Supplier) [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
f. Maintenance procedures and methods records (Supplier)
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. 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
Device History Record. Supplier agrees to comply with Aastrom's Quality Assurance Procedures and Aastrom's engineering documentation for the Product. A Device History Record ("DHR") is to be maintained by the Supplier for assemblies. The DHR shall include, without limitation, lot numbers of components for each Product, any deviations from specifications (for the Product or component) or procedures in the production of the Product, and documentation of any tests or measurement values used in determining the acceptability of the Product or components. Supplier will copy Aastrom on any or all portions of the DHR as Aastrom may request. Any portion of the DHR to be sent to Aastrom will be part of the assembly process and will be controlled by Supplier's documentation change system. It will be the responsibility of the final test technician to insure that this information is passed on to the appropriate Aastrom representative.
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. 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. The Supplier and Customer will agree on which party maintains selected portions of the Device History Record required by the Customer’s QMS. The responsibilities are defined in the following table. Device specifications X Production process specification X Quality assurance procedures and specifications X X Labeling specifications X Packaging specifications X Installation procedures and methods* X Installation records* X Maintenance procedures and methods* X Maintenance records* X Servicing procedures and methods* X Servicing records* X Upon request of the Customer, the Supplier shall make all device history records available within two working days.
