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We Specialize in
510(k)
Documentation
Compliance
Quality
A Specialty for a Specialty
Regulatory compliance and orthodontics have something intrinsic in common - they are both inches wide and miles deep. Get a deep foundational knowledge in both with a consultant who has been in the orthodontic field for more than 14 yearrs.
Take the Pressure Off
Lab owners often carry the burden of compliance on their already-full shoulders.
Knowledge
Looking to learn or train your team on quality? Check out our video series about the role of the FDA for Orthodontic Manufacturers
Documentation
This key component of quality management systems will meet all the requirements set forth by 21 CFR 820.
Engagement
Need a regulatory solution? We offer a range of services from basic compliance to active management.
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