Quality System Changes. Any changes to the status of the Medica Quality System shall be reported to Vapotherm Quality Assurance and Vapotherm Executive Management by sending notice in accordance with Section 14.8 within 72 hours. Status changes may include, but not be limited to the following: (a) ISO Certifications or CE Marking status charges; (b) Process or material failures, including significant vendor related failures or relevant vendor terminations due to quality related issues; and (c) Specification changes for supplemental manufacturing processes, equipment, or materials.
Appears in 2 contracts
Sources: Manufacturing Agreement (Vapotherm Inc), Manufacturing Agreement (Vapotherm Inc)