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| SERVICES & CERTIFICATIONS |
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Registered medical device establishment with the FDA – Seagrove, NC and Donegal,IR |
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ISO 9001:2000 |
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ISO 13485:2003 |
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TS16949 at Ramos, MX facility |
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HACCP |
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Fully compliant to all appropriate regulations of GMP 21 CFR - Part 820 |
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UL Certified |
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Lean Manufacturing |
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Reusable dunnage |
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