Regulatory Insight, Inc. has extensive experience in negotiating directly with regulatory bodies such as the US FDA, Health Canada and notified bodies, to determine the optimal approach to obtain market approval or clearance for a specific medical device or IVD. This translates into the minimal possible cost and time for a company to bring its products to market.

Regulatory Insight, Inc. specializes in the following types of regulatory submissions:

             ]     US FDA 510(k) Premarket Notifications (including Abbreviated & Special 510(k)’s)

             ]     US FDA PMA Premarket Approval Applications (including PMA Supplements)

             ]     US FDA De Novo Applications

    ]     US FDA 513(g) submissions

    ]     US FDA RFD Request for Designation submissions to the Office of Combination Products

    ]     European MDD CE marking

    ]     Health Canada Medical Device Licensing

    ]     Australian Therapeutic Goods Administration (TGA) applications

 Please contact us to learn more about how Regulatory Insight, Inc. can help your company to develop and execute a regulatory strategy to bring your medical device or IVD to market in the quickest and most cost-effective manner possible.