FDA Consulting Services
Bridge Global Health is a medical distributor that specializes in the importation and logistics of foreign made devices and facilitating FDA submissions for US market clearance.
Experience
5+ years of hands-on experience working with foreign manufacturers to bring their Class I–III medical devices to the US Market through the FDA Premarket Notification Submission process (510K).
Expertise
BGH’s team of experts are highly trained in FDA regulation and well versed in the facilitation and navigation of the complex 510K approval process.
Efficiency
We leverage experience and best practices to streamline the quality management process so that clients get their devices to market faster than traditional methods.
Identifying the optimal route for success
Getting a medical device to market is a complex journey. There are often multiple paths that can be taken, but not all paths are quick, painless, or even traversable.
With BGH, you are partnering with a trailblazer. We have been down every path possible, so we have the experience to identify the best route to get our customer’s products to market quick and efficiently.
Regulatory Experience
BGH has extensive experience working with a variety of foreign biotech manufacturers seeking medical device clearance in the US through the FDA. The BGH team works closely with each client to ensure all required documentation is captured early and ready for FDA review. Our team provides expert regulatory strategy and planning to ensure your regulatory pathway is clear, the appropriate predicates devices are identified, and verification & validation is completed. Our team uses the FDA eSTAR submission to streamline the process and ensure quick review and clearance.
Our Process
Kickoff Call
Once a contract is signed, we will schedule a kickoff meeting to make introductions and determine schedule for ongoing meetings and sharing of information.
Weekly Meetings
Stay up-to-date on project milestone and progress through weekly check-ins. Each meeting will have an agenda and minutes to track progress and maintain efficiency.
Ongoing Collaboration
Depending on your quality needs, BGH can provide hands-on document creation, or simple guidance and review.