FDA Consult
US Market Access
for Medical Devices
Over 20 years of experiences in Medical Devices, FDA approval, Inspection, US compliance, Import and US Commerce.
Expert FDA Consulting
Former FDA reviewer guiding you through premarket submission processes such as 510(k), Qsub, De novo, PMA etc.
Ensuring compliance with FDA and other US regulations, such as listing & register, importing, FDA inspection, 483 warning letter response.
Your long term business partner of commercial success in the US market.
US Regulatory Compliance
US Market Access
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Your Trusted FDA Consulting Partner
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
FDA Consulting Services
Expert guidance for FDA medical device premarket review, inspections, and compliance actions.
Premarket Review Support
Assisting with FDA premarket submissions and regulatory pathways for medical devices.
US Business Partner/Distributor for Your Products
We establish long term distribution and/or business partner relationship with international manufacturers who are interested in entering FDA healthcare market.
US Market Access Strategy
Developing tailored regulatory and commercial strategies to meet FDA regulatory requirements and access US market.
Bluebit Medical provided exceptional guidance through our FDA medical device approval process. Highly recommend their expertise!
John Doe
Their knowledge of FDA regulations helped us navigate compliance smoothly. Truly a valuable partner in our journey.
Jane Smith
★★★★★
★★★★★
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