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Launching a diagnostic device requires diligent testing, regulatory approvals, and extensive research. Our full-service Clinical Research Organization (CRO) is here to guide you through every step, ensuring a smooth and efficient market entry. Partner with our experienced team and have confidence in our knowledge of intricacies within the diagnostic device landscape.

In the rapidly evolving world of medical devices, having an experienced CRO by your side can be the difference between success and setbacks. Our team is equipped with the knowledge and resources to navigate challenges and expedite your device's market debut. Achieve excellence with precision and confidence.

1. Regulatory Experience: Our team works in tandem with you during product development to fulfill clinical and regulatory needs, confirming that your device meets the requirements for regulatory approval.
2. Early Feasibility Studies: TE fast-tracks IVD device development with early feasibility study experience. Our team helps verify potential investments and validate conceptual solutions with small-scale usability and pre-clinical studies before incurring the cost of larger validation studies.
3. Regulatory Pathway Consulting: TE offers the study design, protocol writing,IRB submission, subject enrollment, document preparation, and data analysis required for FDA 510(k) and CLIA Waiver submissions.
4. EU & FDA Regulatory Compliance: Obtaining a CE marking in addition to a 501(k) or PMA clearance can be a daunting task. TE can help confirm that your IVD product complies with EU IVDR and FDA regulations. TE can also provide full CRO studies and act as a regulatory liaison to enable that your engineering success is also a regulatory success.