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• ↓ We helped build the CBCT module, got it FDA cleared, and supported them through the Varian acquisition.
• ↓ We Got a Teleradiology Startup FDA Cleared in Under a Year — Without an In-House Regulatory Team
• ↓ We went from Zero Documentation to 510(k) Cleared in 12 Months
• ↓ We Turned a Cybersecurity Hold Letter into an FDA Clearance in 3 Months
• ↓ We Flew Onsite, Read the Code, and Finished the 510(k) Docs in 4 Months
• ↓ We resolved a hold letter that threatened a clinical study redo and got it 510(k) cleared on Christmas Day.
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"You need a software-development partner for a new or existing medical-device product."

"You need to determine the best path to the US market or have other custom regulatory needs."

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We helped build the CBCT module, got it FDA cleared, and supported them through the Varian acquisition.

We Got a Teleradiology Startup FDA Cleared in Under a Year — Without an In-House Regulatory Team

We went from Zero Documentation to 510(k) Cleared in 12 Months

We Turned a Cybersecurity Hold Letter into an FDA Clearance in 3 Months

We Flew Onsite, Read the Code, and Finished the 510(k) Docs in 4 Months

We resolved a hold letter that threatened a clinical study redo and got it 510(k) cleared on Christmas Day.