Analytical Performance
Analytical performance demonstrates the ability of your device to correctly detect or measure a particular analyte.
Our evaluation study support can assess a range of measurements that include:
- Analytical Sensitivity (LOD)
- Analytical Specificity (Interference & Cross Reactivity)
- Precision (Repeatability & Reproducibility)
- Matrix Equivalence
- Measuring Range (Hook Effect)
- Flex & Robustness Stability (Shelf life, Shipping & In Use)
Clinical Performance
A clinical performance evaluation of a device describes the process of assessing the safety and performance of the device when used as intended by the manufacturer.
Our evaluation study support can assess a range of measurements that include:
- Clinical Performance
- Clinical Trial
- Usability Study
Why partner with us?
Navigating the complexity around regulatory requirements is part of the day-to-day for the team here at Abingdon Analytical and guiding you through these is the fundamental part of your submission journey with us.
Our performance evaluation study plans are structured with the intended certification as a reference point (inclusive of FDA and IVDR) to ensure that devices will meet all the applicable regulatory standards, plus demonstrate a commitment to both an objective and comprehensive evaluation of the medical device’s performance.
Abingdon Analytical’s team of multi-disciplinary experts are comprehensively trained in line with the standards and guidelines such as the CLSI, ICH and ISO, and have extensive experience in delivering projects time and time again.
From the fully equipped lab at our Doncaster site, as well as via our network of clinical trial sites around the world (covering the UK, EU and USA), Abingdon Analytical help design and development projects like yours to take the next step in their submission journey.
Design & Development Support
We appreciate that being heavily invested in the earlier stages of your project means you might not have looked ahead of the development and considered what’s required to move it forwards.
Help To Overcome Obstacles
Whether the obstacles you are facing are financial, regulatory or technical, Abingdon Analytical works alongside you, helping you to save time and costs across the whole timeline of your project.
Move Your Project Along
Performance evaluation is a critical step of the regulatory submission for an IVD to be approved for release onto the market. Get in touch today to find out how our team can support your project.
Request a consultation
Speak to a member of the Abingdon Analytical team.
