The right in vitro diagnostic (IVD) device can streamline clinical trials and expedite personalized patient care. We deliver world-class assistance for your IVD device development. We’ll help you build out effective research studies and protocols designed to validate algorithm reliability and validity.
With Avania, you’ll have a top-notch regulatory team helping you communicate with relevant regulators while navigating complex evaluations. Whether your product utilizes a general purpose reagent or an analyte specific reagent, we can support you from pre-submission, through IDE submission and clinical trial execution, and finally to a 510(k) clearance or PMA approval..
Avania is experienced with analytical studies using clinical samples or a prospective clinical study for IVD clearance. Avania can also support protocol development and study design to assess the clinical validity of a new device, investigating the clinical sensitivity and clinical specificity or agreement.
Then, once your product is cleared, we will leverage our connections and industry knowledge to accelerate your device to market.
With a customer-centric approach, we focus on your individual needs to create a tailored solution.