Monday, November 06, 2023
AliveDx, a globally recognized leader in the in vitro diagnostics industry headquartered in Eysins, Switzerland, proudly announces its successful acquisition of IVDR certification for its state-of-the-art manufacturing facilities located in Eysins, Switzerland, and Edinburgh, United Kingdom. This remarkable accomplishment underscores AliveDx's unwavering commitment to adhering to the highest quality standards, as they align with the In Vitro Diagnostic Regulation (IVDR) as outlined in EN ISO 13485:2016.
This certification is a testament to their meticulous adherence to the intricate regulatory requirements governing in vitro diagnostics, replacing the former In Vitro Diagnostic Directive (IVDD). This significant certification further underscores AliveDx's dedication to delivering top-tier solutions to healthcare professionals and patients, spanning their comprehensive product portfolio, encompassing Alba (dedicated to transfusion solutions) and MosaiQ® (providing multiplexing and multimodality automated clinical diagnostic solutions).
The IVDR certification marks a pivotal milestone for AliveDx, reinforcing their steadfast commitment to collaborating with their customers and ensuring access to premium in vitro diagnostic solutions.