Fax: (317) 298-2055
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 most recent registration renewal from the FDA covers dsi through the year 2003. |
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| http://www.divsys.com | ||||
| http://www.rapidproto.com | ||||
| Voice:
(317) 299-9547 Fax: (317) 298-2055 |
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| sales@divsys.com |