Regulatory Submissions – Ensuring a Clear Path to a Successful Launch

Getting regulatory approval of your medical or drug delivery device is critical. Our innovation consultation process takes regulatory requirements and guidance into account from the very start of development. As the regulatory strategy we develop for your project unfolds, the path to successful commercialization becomes clearer and further defined.

Here are a few examples of what we do to help clear the path:

  • Prepare a regulatory assessment specific to your medical device, specifying device classification and how to get your product to market
  • Submit a 513(g) or Pre-Submission package for additional regulatory input from FDA
  • Direct correspondence with FDA about general topics through the Division of Industry and Consumer Education (DICE) or Small Business and Industry Assistance programs
  • Research and identification of applicable regulatory requirements, guidance documents and recognized consensus/harmonized standards
  • Include consideration for regulatory compliance throughout the design and development process, as well as understanding of the required regulatory elements during appropriate phases of the project
  • Pay special attention to patient safety, risk and human-centered design
  • Authorship of various regulatory documentation:
    • Letters to file
    • 510(k)
    • Technical files (CE mark)
    • Supporting companies by providing key documentation for their IDE, IND or PMA submissions
  • Strive for reduced review cycles with regulatory agencies
  • Interact with regulatory agencies and FDA’s Certified Third Party Reviewers
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Regulatory Submissions – Ensuring a Clear Path to a Successful Launch

The regulatory process can be challenging, no doubt about it. We take this very seriously, setting you up for success in advance so that regulatory reviews do not become a major hurdle for commercialization of your medical device.

510(K) Regulatory Submissions – Getting it Done

Long before we make the 510(k) regulatory submission, we build a solid strategy for:

  • Incorporating regulatory expertise upstream in the device design and development stages
  • Balancing patient safety with speed to commercialization
  • Understanding what regulatory agencies in the submission

510(k) Clearance through the FDA – Market, Sell and Distribute Medical Devices in the US

With numerous successful 510(k) submissions under our belts, we bring a wealth of knowledge to your project. We’re experts at writing and preparing the documentation needed for 510(k) submission, leading to:

  • Reduction in the number of review cycles
  • Effective communication directly with regulatory agencies, including interpretation of their requests and questions during the regulatory review process
  • A quicker path to commercialization

Because we have internal regulatory expertise, there is no hand-off required between project team members designing your medical device to an external consultant, making the process more efficient both in time and likely costs.

For further details on FDA’s 510(k) review process.