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Dentallabnetwork.com
Outsourcing Concerns- FDA Regulations-ADA Regulati
DAMAS, GMP Study Club in FaceBook
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<blockquote data-quote="Tom Moore" data-source="post: 64062" data-attributes="member: 1247"><p>Mark,</p><p></p><p>Are you going to get Medical Device ISO 13485-2003 certification? I believe in the end the easiest path is going to be paying for third party certification and annual inspections to satisfy FDA registration requirements. Texas uses the NBC/CDT as a standard for registering a lab to do business with a Texas Dentist. I can see the FDA doing something very similar.</p></blockquote><p></p>
[QUOTE="Tom Moore, post: 64062, member: 1247"] Mark, Are you going to get Medical Device ISO 13485-2003 certification? I believe in the end the easiest path is going to be paying for third party certification and annual inspections to satisfy FDA registration requirements. Texas uses the NBC/CDT as a standard for registering a lab to do business with a Texas Dentist. I can see the FDA doing something very similar. [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
DAMAS, GMP Study Club in FaceBook
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