Accelerate your product development.

Regulatory Services

Work with a dedicated team.

When you partner with MED Institute for support with regulatory submissions, we listen to your needs to help you determine your regulatory path to approval. The regulatory process can be a long one, but throughout we will treat you like a colleague, not a client.

MED Institute can help you develop regulatory strategies for everything from product development to final marketing approvals and postapproval support. At every stage, we use fundamental science and data to show how your product meets regulatory requirements.

Did you know MED Institute …

  • Has worked on 1 original NDA and 12 FDA-approved original PMAs, including the PMA for the first FDA-approved coronary stent and the PMA for the first FDA-approved drug-coated peripheral stent?
  • Has worked on over 40 IDEs?
  • Personnel have helped clear over 70 original 510(k)s over the past 25 years, in every division of FDA’s Office of Device Evaluation?
  • Obtained the first ever Humanitarian Device Exemption from FDA in 1997 and obtained a second one in 2013?