FDA/CE Approval
Focus more on the actual work and less on getting the work approved.
What is it?
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.
Learn more
Why is it important?
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:
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!
Fill out a 2-min survey
Build cool stuff. Leave the headaches to us.
Talk to our team to learn how we can best support you.
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