510(k) Submissions
Streamlined Submissions for Faster FDA Clearance
We manage your 510(K) submission, using our extensive regulatory expertise to navigate requirements and accelerating approvals. Our team knows the process inside and out which allows us to move your device through the process as quickly as possible.
Why It Matters
The 510(k) submission process is complex and nuanced. It can be far more time-consuming that it needs to be without a proven strategy. Our team will structure your submission, identify the predicate device(s) to support it, and address FDA requirements proactively to avoid process issues.
Our Approach
We begin the process by developing a submission plan built upon our years of expertise in obtaining 510(K) approvals. Throughout the device development process we build and gather all of the necessary information for the submission package to ensure you are prepared for approval.
Our 510(k) Submission Services Include:
Pre-Submission of Guidance & Documentation
Predicate Device Analysis and Comparison
Substantial Equivalence Justification
Safety and Performance Documentation
Regulatory Strategy and Communication with FDA
Full HF/UE Documentation Package
Labeling & Instructions for Use (IFU)
Risk Management File
What You Get
A complete, submission-ready 510(k) package with all required documentation and data. Our strategy positions your device for fast, successful approval.