BlueBit Medical
With over 20 years of experience in Medical Devices, FDA approvals, Inspection, US compliance, and US commerce here at BlueBit, we are ready to help.
Expert FDA Consulting
With over 20 years of experience from former FDA reviewer, BlueBit Medical specializes in FDA consulting for medical device premarket review, inspections, and regulatory compliance, ensuring your products meet all U.S. regulations smoothly.
20+
100+
Successful FDA Approvals and positive FDA interactions
MedTech partners from US, Europe and China
US Market Access
We help foreign manufacturers gain access to the U.S. market by providing the tools, strategies, and support needed to successfully launch and sell their products. From navigating regulatory requirements to developing go-to-market strategies, we streamline the process of entering the U.S. retail and eCommerce space, ensuring a smooth and scalable expansion.
Our Location
Located in Maryland, we specialize in FDA consulting for medical devices, ensuring compliance and successful premarket reviews.
Maryland
123 Main St, Maryland
Hours
9 AM - 5 PM