Eysins, 6 November 2023 — AliveDx a global in vitro diagnostics company headquartered in Eysins, Switzerland, today announced it has now received IVDR Certification for both its state-of-the-art manufacturing facilities located in Eysins, Switzerland and Edinburgh, United Kingdom.
AliveDx is proud to announce its manufacturing facilities have been granted In Vitro Diagnostic Regulation (IVDR) certification through EN ISO 13485:2016. It confirms the new and extensive IVDR requirements are met by both AliveDx sites. This certification is a prerequisite for any manufacturer of in vitro diagnostic solutions (IVDs) to continue to sell in the European Union (EU) while the industry transitions away from IVDD.
The certification underscores our commitment to delivering high-quality solutions to healthcare professionals and patients across our businesses: Alba –– transfusion portfolio –– and MosaiQ® –– multiplexing and multimodality automated clinical diagnostics solution.
“The IVDR certification is a significant milestone for our organization. It reinforces our unwavering commitment to partner with our customers in providing high-quality in vitro diagnostic solutions. We are dedicated to upholding the highest standards of quality, safety, and compliance. It is a testament to our pursuit of excellence to empower diagnostics insights, transform patient care and innovate for life.” said Manuel O. Méndez, Chief Executive Officer of AliveDx.
The In-Vitro Diagnostic Medical Device Regulation (IVDR) has replaced the previous In-Vitro Diagnostic Medical Device Directive (IVDD). The IVDR was published in May 2017, marking the start of a multi-year period of transition from the IVDD.
About EN ISO 13485:2016
TheEN ISO 13485:2016 is an international harmonized standard for Quality Management Systems that demonstrates manufacturers’ ability to meet the IVDR quality requirements.
At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster disease detection to shorten the time to diagnosis. Alba–– our transfusion portfolio–– and MosaiQ®–– multiplexing and multimodality automated clinical diagnostics solution –– are designed to make laboratories more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life. ©AliveDx Holdings Finance Company Ltd, 2023. MosaiQ is a trademark or registered trademark of AliveDx Holdings Finance Company Limited or its subsidiaries in various jurisdictions. Menus and capabilities are subject to change. Not all methods may be available in all territories. Subject to regulatory clearance.