Our team of experts provides regulatory and product development consulting services to our clients for device products regulated by CDRH. Dunn Regulatory Associates, LLC has a track record of efficient, success-driven regulatory strategy and implementation. Our consultants bring decades of experience in product development.

Our expertise in devices includes:

  • FDA Submissions and Interactions
  • Clinical Trial Design and Evaluation
  • Drug Device Combinations
  • Digital Therapeutics
  • U.S. Agent Services

Our device expertise spans across dermatology, pulmonary, psychiatry, ophthalmology, and infectious disease. Our team possesses the skills and knowledge to bring your product to the market quickly and efficiently.

We have specific expertise in the following:

  • Drug Device Combinations
  • Human Factors Studies
  • 510(K)s
  • 513G
  • IDEs/PMAs

Our goal is to work collaboratively with device manufacturers to bring novel, life changing technologies to patients quickly and efficiently. Our regulatory expertise allows us to develop innovative strategies in conjunction with world class science to help you achieve your goals and improve the lives of patients.

In doing so, we look at every project through the lens of the patient. approaches, world-class science, regulatory know-how and a dedicated team to deliver solutions that improve patient access and quality of life for patients.