For your Class III IVD devices that are considered to be high-risk and for which there is no legally marketed predicate device, we help demonstrate that the device is safe and effective for its intended use.
Demonstrating the safety and efficacy of your device
Our on-staff regulatory experts understand the unique landscape in medical device and diagnostics. With proven expertise in all manner of studies— PMA; 510k equivalence, and de novo submissions—we are prepared to answer your FDA-related questions and review and support submissions.
Regulatory pathways
No matter your therapeutic area, we can provide regulatory strategies, manage pre-submission meetings with regulatory bodies, and assist with regulatory pathways.
IDE preparation including pre-IDE meetings.
For your Class II and III IVD devices in the United States, we can support your Premarket Notification (510(k)) to the US Food and Drug Administration (FDA) that demonstrates substantial equivalence.
For your low to moderate-risk Class II devices that do not meet the criteria for the 510(k) pathway, but still require regulatory clearance or approval.
For your IVD devices planned for the European Union. The IVDR framework that replaces the In-Vitro Diagnostic Directive (98/79/EC) introduces new requirements for the marketing and labeling of IVD devices, as well as new performance and quality standards.
Let's discuss your project
Contact our pharma solutions experts to design a custom program to accommodate the needs of your study.
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