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