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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."

"You need help preparing cybersecurity documents for an FDA submission or to respond to a Hold Letter."

"Empower medical device innovation with our solutions for particular business situations."

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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.