Validation & Verification and Clinical Comparator Laboratories
The work performed in our verification & validation and clinical comparator laboratories supports the diagnostic device product lifecycle from early-stage studies through regulatory approvals, enabling market access for our customers.
From initial assay design metrics to analytical validation through EUA and 510(k) submission filings through FDA, our expertise and instrumentation support performance of this work at a world-class level, while accelerating product approvals and market access for our customers.
Our expertise supports evaluation of emerging diagnostic technologies for our clients with expertise in the record retention and support for ongoing clinical submissions. Our support continues into the post-market deployment, where diagnostic devices meet real-time, emerging disease state trends. We then also meet the ever-evolving needs of our customers by providing the instrumentation necessary to respond to new disease outbreaks.