We complete your 510(k) review in ≤65 days
Our experience in all in-vitro diagnostic (IVD) scientific, pre-analytical, analytical, biological, and clinical aspects enable us to fully understand and guide you through the 510(k) review process.
EfficiencySave up to 65% of the FDA review time (65 vs 203 days on average). See the Review Process
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FlexibilityAccommodate your deadlines and streamline the workflow accordingly
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Competitive Cost
One simple fee to conduct the review and communicate with the FDA on your behalf- No FDA User Fee or surprise costs
Exceptional Quality of ServiceDedicated to delivering excellent customer service and creating open and honest relationships with our clients
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Transparency and DedicationEncourage and appreciate client feedback; committed to addressing any concerns to our clients' satisfaction
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Streamlined CommunicationPromote direct client interaction with your designated reviewer
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