Segmed -FDA/CE Approval Software
FromSegmed, Inc.
Focus more on the actual work and less on getting the work approved.
SaMDs need to be approved by the FDA. The process can be tedious, painful, and unclear - it’s not clear what the requirements even are! ??
That’s where Segmed can help. Our team works with companies to:
That’s where Segmed can help. Our team works with companies to:
- Understand the FDA requirements for both locked and dynamic machine learning models
- Fill out an application that will be approved
- Submit the application and necessary paperwork for you
- Store the results for future applications, audits, etc.
SaMD’s need FDA approval to be used in your application, trial, study, or body of work.
You should be focusing on the actual work, and not getting the work approved. Let us handle it now, and all the headaches going forward!
Get access to:
- Age, gender and demographic breakdowns of your purchased data
- An experienced team of clinician-scientists who will support you and your team on your journey to FDA approval and/or CE clearance.
Get in touch, and tell us more about what you`re looking for!