Clinical Performance Data (for Clinical Laboratories)

The clinical performance of the IONA® NIPT Workflow is assessed as part of the development process prior to product launch. Post-launch, as required by the medical device regulation and for our quality system we monitor performance via a process called ‘post-market surveillance’. Post-market surveillance is a set of activities conducted by manufacturers to collect and evaluate experience gained from medical devices that have been placed on the market. It is done with the intention of ensuring we can identify any trends that suggest the need to take any action e.g. withdrawing a faulty batch from the market.

 

The data from both the initial validation work and post-market surveillance activities is provided below.