Regulatory Statement

 

CLI is a business-to-business component manufacturer addressing the diagnostic ultrasound industry and, as such, provides no finished goods to clinicians.

Any and all regulatory filings and/or approvals necessary to market finished goods containing CLI components are the sole responsibility of CLI’s customers. Similarly, all mandated reporting requirements (e.g., MDRs or similar) are the responsibility of the customer.

As a matter of good business practice, CLI maintains a Quality System in compliance with FDA Good Manufacturing Practice (GMP) guidelines and ISO 9000 regulations. CLI is not ISO 9000 certified; however, CLI is regularly audited by its ISO 9000-certified customers and is in good standing with each as a Qualified Vendor. CLI maintains a “complaint” database as part of this practice and will share data with its customers, with respect to a particular customer’s designated products, to aid in the customer’s compliance systems.

CLI makes no warranty concerning any product’s fitness for a particular use. Fitness for use must ultimately be validated by the customer. Applications listed within this website are intended to be suggested applications, or, in some cases, applications where CLI’s customers have found the products to be useful.