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!
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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.
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