Qualcon Renews US FDA Registration and cGMP Certifications

Flowery Branch, Georgia USA

April 4, 2008

Qualcon announced today that the United States Food and Drug Administration has renewed its Registration (#3004546535) enabling Qualcon to continue manufacturing and servicing Class I, II and III FDA-approved medical devices. In addition to the general FDA registration, Qualcon also manufactures, distributes and services (worldwide) three FDA-approved devices for its customers under its FDA cGMP. Flextronics, the largest contract manufacturer in the world, carries seven FDA cGMP registrations for its customers.

While many contract manufacturers hold the US FDA Registration, such certification does not enable those firms to build and ship FDA-approved products directly into the sales channel. The most rigorous certification applying to such service is the US FDA cGMP (current Good Manufacturing Practices) Registration. Consequently, very few contract manufacturers are FDA cGMP registered. The entity that ships the FDA-approved product into the sales channel (to distributors, wholesalers, retailers, or the end-user) MUST hold the FDA cGMP Registration.

 

Qualcon CEO Bob Bilbrough stated, "While ‘OEM’ once stood for ‘Original Equipment Manufacturer’, today the acronym means "Outsource Everything but Marketing". Qualcon’s possession of FDA cGMP and ISO 13485 registrations enable the ‘virtual OEM’. With Qualcon’s registrations, medical device companies are no longer required to invest a year and as much as a half-million dollars to get an FDA-approved device into the market. Qualcon is the only high-mix / low-volume contract manufacturer in the U.S. qualified to ship FDA-approved medical devices directly to our customer’s customers worldwide, and to provide international warranty/repair depot services for those products. "

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Based in the Atlanta suburb of Flowery Branch, GA, Qualcon provides continuous flow electronics manufacturing services, including turnkey material procurement and assembly, box-build and deployment services, labor-only assembly of customer-consigned components, functional and in-circuit testing and life-cycle management services to Original Equipment Manufacturers in the electronics industry.

Qualcon receives international recognition for their pioneering practice of CONTINUOUS FLOW MANUFACTURING in the electronics manufacturing service provider industry.

Qualcon is ISO 9001:2000, ANSI/ESD-S20.20-1999, FDA cGMP, ISO 13485:2003, BABT, UL, ETL registered and Telcordia (Bellcore) and QS-9000 compliant.

Qualcon is the two-time recipient of the Pacesetter Award as one of "Atlanta's Fastest Growing Private Companies."

For more information, please see our web site at http://www.qualcon1.com  or contact:

Bob Bilbrough

Phone: 770-965-3300

Fax: 770-965-9142

Email: bbilbrough@qualcon1.com