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)
Appears in 2 contracts
Sources: Quality and Manufacturing Agreement (SI-BONE, Inc.), Quality and Manufacturing Agreement (SI-BONE, Inc.)