IVD CRO Services

TE's Clinical Research Organization (CRO) conducts cost-effective clinical studies for IVD consumables, instruments, and other devices. TE provides all appropriate clinical trial planning, study design and execution, protocol development, IRB approval, data management, and report writing services.

Early Feasibility Studies

TE fast-tracks IVD device development with early feasibility study expertise. Our experts help verify potential investments and validate conceptual solutions with small-scale usability and pre-clinical studies before incurring the cost of larger validation studies.

Regulatory Pathway Consulting

TE´s expertise with FDA regulations, liaising, feedback, and approval pipelines for IVD devices helps increase cost effectiveness and chances of clearance. 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.

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 ensure 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 ensure that your engineering success is also a regulatory success.