BNR medical device approvals
ACCELERATING the compliance process
BNR Medical Device pprovals is a group of medical device industry veterans with decades of experience in Compliance Consulting, Project Management, Regulatory Affairs, Lab interface and best practice insights.
BNR Medical's extensive medical device experience, engineering depth and proven approval systems enable us launch your medical device on-time.
BNR consists of a strategic teams of engineers, doctors, and designers working together to streamline your FDA 510(k), PMA, EMC & Safety Agency submission process.
Third-party Review FDA 510(k) Third-party Review Services.
Incorporating decades of medical device experience and expertise preparing FDA 510(k) submissions for the US/Canadian Markets...as well as international certifications. BNR Medical assists manufactures, exporters and distributors of medical devices. We have the accurate insights to adequately prepare for, comply with and navigate through the regulatory process.
- A 510(k) is a premarketing submission made to the FDA to show that the medical device is safe and effective, substantially (SE) to a legal device that is not subject to pre-market approval (PMA)
- Unless the device is exempt from 510(k) requirements, then a 510(k) (premarket notification) to FDA at least 90 before marketing the product.
Call 408-674-9184 or email (info@bnrmedical.com) to get BNR's expertise applied to your specific situation
