IVDR compliance achieved

QMS and products of Xpedite Diagnostics have been updated to ensure full IVDR compliance. CE-IVD kits for rapid extraction of RNA and DNA, SwiftX Swabs and SwiftX Media, now Class A products under IVDR.

 

 

With Date of Application of the new EU regulatory framework, the IVDR (EU) 2017/746, it was necessary that we upgraded our QM system and the Technical Documentation of our two CE-IVD products, SwiftX™ Swabs and SwiftX™ Media. We achieved this milestone just in time, which is why we can continue to sell these rapid RNA extraction and DNA isolation kits as medical devices. Key to reaching this goal was the expertise of our CEO, Dr. Andy Wende, who has been a Lead Auditor and Product Assessor for IVD devices at the world's largest Notified Body for medical products - TÜV SÜD.