Securing FDA clearance or approval and bringing a medical device to market can be challenging.

Let us help you navigate the complexities.

IVDx Consulting provides strategic, clinical, and scientific consulting and guidance to companies that want to market in vitro diagnostic medical devices in the United States

We can help with all your regulatory and scientific needs

We Offer:

  • Regulatory strategies to successfully comply with FDA policies and processes
  • Expert advice on FDA guidelines and requirements for development and validation of in vitro diagnostic devices
  • Management of FDA interactions including writing and editing submissions and leading all direct communication with the FDA
  • Analysis of analytical and clinical validation studies for submission to the FDA

Reasons to work with us

Trust

We build relationships based on mutual trust and respect. We are committed to the success of your organization.

Communication

We understand the critical importance of teamwork and communication to achieve success. Our strong written and oral communication ensures effective and efficient communications with the FDA. IVDx strives for transparency at every level and will always provide honest and direct feedback and expert advice.

Impact

We deliver results on many levels: success with the regulatory process; alignment of regulatory, business, and scientific goals; timely achievement of milestones; and ensuring your organization has positive impact on individual patients and public health.

Experience

We have experience working with devices at all stages of development and validation. IVDx offers a deep understanding of how to efficiently steer a device through the regulatory process. We work in team-oriented, results-focused environments to achieve success.