Regulatory Submission and Approval
Worldwide regulatory requirements can vary substantially. Fathomís team is experienced in both FDA and CE-mark approval processes and will assist in your rapid and successful regulatory submission.


Guidance Documents & Standards
Fathomís experts are familiar with the accepted guidance documents (FDA, ISO, etc.) and will assist with the interpretation and evaluation of your device to ensure compliance with the appropriate standards.

Submission Packet
Regulatory reviewers examine hundreds of submissions annually. Our affiliate consultants are former FDA reviewers who will craft your submission dossier for ease of review in a clear, concise, and complete package.



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