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CLASS THREE, LLC
Medical Device Regulatory Consulting
Specializing in higher risk and novel devices:
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Class I and II De Novo
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Class III Premarket Approval
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Class 2 and 3 EU Design Dossiers
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Device classification
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Regulatory path assessment
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FDA pre-submission meetings
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IDE applications
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De novo requests
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EU design dossiers
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EU technical files (MDD/MDR)
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EU clinical evaluation reports
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Cardiovascular
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Orthopedic
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General and Plastic Surgery
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Obstetric and Gynecological
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Opthalmic
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Dental
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Diagnostics/LDTs
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