Commercial Readiness for MedTech
Scaling from R&D to Revenue without the regulatory roadblocks.
Regulatory Gaps
Your QMS got you cleared, but can it handle commercial supply chain volume?
The Gap Between Approval and Revenue
Reimbursement Voids
FDA clearance doesn't guarantee payment. Don't launch without a code.
Scale Risks
Transitioning from R&D to manufacturing is where most recalls happen.
Commercial Assurance
clearance does not guarantee a successful launch. We rebuild your R&D quality system to handle commercial volume so you don't face a warning letter or recall
Market Access Strategy
FDA clearance is worthless without payer coverage. We align your clinical data with insurance requirements to ensure you get paid, not just approved.
Trusted by Series A and B MedTechs
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Essential to achieving coding and coverage based on existing clinical data
CEO, Series B Robotics
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Addressed critical QMS gaps to ensure regulatory compliance
CEO, Series A Neurology
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Rapidly set up QMS for global product launch
Global GM, Smart Health