WE PROVIDE EXPERTISE AND INSIGHT TO HELP YOU INITIATE THE RIGHT PATH FOR YOUR MEDICAL DEVICE.

Strategy Plans and Business Development

It can be a challenge to identify objectives in the research, development, and marketing of a medical device. We help you understand what steps to take in order to move your medical device to market, answering questions like — How does the regulatory process work? What challenges might arise? What are the best practices when submitting an application? How can we best navigate the process?

Determine U.S. Food & Drug Administration (FDA) Oversight for your medical device

With deep knowledge of the various offices and divisions within the FDA, we can help you determine a high-level strategy for moving your device to the U.S. marketplace.

Identify Pathways for your medical device

If you are working with the FDA for the first time — whether you are new to the medical device world or new to the U.S. regulatory process — we can help determine the appropriate pathway for your device or drug-device combination product (e.g., Pre-Market Approval, 510K, DeNovo, or Humanitarian Device Exemption).

Contacting the FDA

We take the guesswork out of whom to contact at the FDA, helping you establish contact with the right people to answer your questions and facilitate the process.