Regulatory Affairs
At Folio Consulting Group, LLC, we provide Regulatory Affairs expertise for start-up, mid-size, and global medical device, biologics, and in-vitro diagnostic companies. Folio Consulting Group has experience completing the following:
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Regulatory Strategies
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510(k) Notifications
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De Novo Classification Requests
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FDA Small Business Qualification Applications
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Premarket Approval (PMA) Applications
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PMA Supplements
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Investigational Device Exemptions (IDEs)
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Humanitarian Device Exemption (HDE) Applications
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FDA Pre-Submission Meeting Requests (Q-Submissions)
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EU MDD Tech Files and Design Dossiers
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EU MDR Technical Documentation for CE Mark
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We can help develop your regulatory strategy for Class I, II, or III Medical Devices, IVDs or Combination Products. We can also partner with your team to lead meetings with FDA to discuss controversial topics such as device risk, device down-classification (de novo), clinical study strategy, and human factors studies. We are skilled at leading teams towards unlocking the regulatory barriers to entry in the medical device and in-vitro diagnostic market. Reach out to us to schedule your free 30-minute initial consultation.
