Certifications: FDA Registration
Volume
2, Number 3, November 2002
| Medical
device manufacturing represents approximately 30% of dsi’s
revenue and is one of five industry segments in which we operate. (Automotive,
Telecom, Military/Aerospace, and General Industrial are the others.) dsi
maintains the audited certifications for every industry segment in which
we participate. According to the IPC, dsi is the
only member holding all major quality certifications. |
| All
medical device manufacturing companies (including contractors) are required
by the Food and Drug Administration (FDA) to maintain a quality system that
complies with its Current Good Manufacturing Practice (CGMP). These requirements
govern the methods and controls used in the design, manufacture, packaging,
labeling, storage, and shipment of all medical devices intended for human
use. Their purpose is to ensure that these devices will be safe, effective,
and in compliance with the Federal Food, Drug, and Cosmetic Act as appropriate. |
| Medical
device manufacturing companies are required to renew their registration
on a yearly basis. The registration renewal process may involve an unannounced
audit by FDA inspectors. The FDA audit includes verification of CGMP compliance
regarding document control, production and process control, identification
and traceability, purchasing control, inspection, corrective and preventive
action, labeling and packaging control, nonconforming product control and
other aspects of production. Compliance with these comprehensive requirements
promotes consistency in quality, safety and efficacy of medical devices.
|
| Through
its strong commitment to quality, dsi ’s management
ensures the corporate-wide implementation of these rigorous regulations.
As part of our ongoing effort to maintain the highest levels of customer
satisfaction and to meet our business goals, dsi
renews its registration annually, guaranteeing uninterrupted service to
the medical device industry. Our FDA registration is renewed on a periodic
basis to maintain our qualification as a medical device manufacturer. |
|
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