Common use of Quality Systems Clause in Contracts

Quality Systems. Centogene shall be obliged to maintain and diligently document a quality assurance system and a risk management system for the manufacture and supply of Contract DBS Test Kits in accordance with Applicable Laws, Standards and Regulatory Approvals as evidenced by certificates from Regulatory Authorities, such certificates to be based on Applicable Laws and Standards governing the manufacture and distribution of the product, as classified on the Effective Date. In the EU. the Contract DBS Kit is, as of the Effective Date, classified as a Class I IVD device. Centogene’s quality systems shall include written policies and procedures that address, at a minimum, the following: Quality System including: design control, training, supplier & purchasing controls, supplier audits, vendor change notifications, facilities and equipment, exception / deviation notification, Complaint reporting and CAPA; facilities and equipment systems; laboratory control systems; data protection, protection of IT networks.