TE Connectivity is experienced in IVD clinical studies, regulatory submissions and clearances. Our team works in tandem with you during product development to fulfill all clinical and regulatory needs, ensuring that your device meets all requirements for regulatory approval.
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.
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.