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.
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