Precision Manufacturer
of Medical Implants
and Instruments
ISO 13485: 2003 certified
ISO 9001: 2000 certified
FDA registered
HUBZone approved supplier
PEEK machining specialists
Advanced Metrology
Cages

Certifications

ISO 13485:2003 certified
(Registrar: NSF International)
Click to view or download a copy
ISO 9001:2000 certified
(Registrar: NSF International)
Click to view or download a copy
FDA registered - 1836249
 
SBA HUBZone certified supplier - 23265
(supportive to OEM's Diversity Supplier goals & objectives)
Verification and Validation of Manufacturing Processes
IQ/OQ/PQ reviews and testing of critical processes and equipment
Validation Master Plan available for customer review
FDA cGMP QSR in review
Compatible with ISO 13485:2003 and ISO 9001:2000
AS9100 certification in review
Surveillance audit planned 1Q 2010

 


 


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