Quality Requirements and Reporting Sample Clauses

Quality Requirements and Reporting. 7.1. the Buyer undertakes to ensure a traceability system of the goods by maintaining suitable record of the goods reference, lot or serial number, quantity and customer information, during at least five (5) years for disposable products and seven (7) years for active equipment. 7.2. The Buyer shall store, handle and transport the goods to its customers in accordance with the product specifications and with the last version of the Good Distribution Practices guideline as published by Eucomed (▇▇▇.▇▇▇▇▇▇▇.▇▇). 7.3. The Buyer must report to DIALEX within two (2) business days, any incident communicated by its customers, end-users or service agents and/or by local authorities involving an injury or potential injury of a patient or user and related to the use of the goods. The Buyer must report by e-mail (▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇) to DIALEX within one (1) business week from being informed, any complaint, malfunction or defect related to the goods communicated by its customers, end-users or service agents.