ISO 13485:2016 Certification Awarded to Alveo Technologies

Alveo Technologies Inc.’sc quality management system (QMS) has achieved ISO 13485:2016 certification for the design, development and manufacture of in-vitro diagnostic kits and analyzers for infectious disease detection. 
 
The globally recognized ISO 13485 standard, published by the International Standards Organization, sets  out requirements for establishing and maintaining quality management systems for the medical device industry.

“We are thrilled to achieve ISO 13485 certification,” Alveo CEO Shaun Holt said. “This official recognition from our notified body confirms that Alveo Technologies has developed a quality management system that delivers highly sensitive and specific molecular sensing and diagnostic results. We are committed to maintaining this standard and driving quality for our customers and partners. I would like to emphasize that this is more than a piece of paper—it is proof positive to the world that our intense focus on quality has been independently verified. Moreover, this assures current and future partners in agriculture, veterinary sciences, and aquaculture that we bring a high level of quality to their projects, their markets, and customers. ”
 
Compliance with the ISO 13485 standard is required for companies to market medical devices in many markets, including the European Union, Canada, Japan, and Australia. In addition, the U.S. Food and Drug Administration has announced plans to harmonize its existing medical device QMS requirements with ISO 13485, proposing new regulations that incorporate ISO 13485 as the foundational requirements. 
 
Alveo has developed a rapid, handheld, eco-friendly, multiplexed platform that pairs advanced molecular assays with cloud-enabled data analytics for real-time disease, pathogen and contaminant detection, analysis, and diagnosis. This mobile molecular lab is capable of delivering rapid testing at the point of need, for example, in doctor’s offices for various infectious diseases, in the field for crop testing, or on farms for livestock testing. Alveo is leading the transformation of the point-of-need molecular sensing and health tech markets with an open-platform approach to co-developing rapid molecular testing capabilities with collaborative partners across multiple markets.  Initially focused on COVID-19 testing, the company has commercialized its be.well COVID-19 test in the European Union, Middle East, and the Caribbean on the basis of this certification.
 
Alveo’s conformity assessment was performed by GMED-LNE, a French notified body globally renowned for its expertise in assessing medical device quality management systems for conformance to the standard. GMED (CE 0459) is designated as a Notified Body under Regulation (EU) 2017/746 and is one of only a few authorized to provide certification services to manufacturers according to Regulation (EU) 2017/746 (IVDR).
 
“This certification from GMED, one of the world’s most respected notified bodies, confirms that we have a top-notch quality management system for the design and development of compliant IVD products,” said Kevin Gunning, vice president of Quality at Alveo. “In executing against our development pipeline, our QMS processes give us a high degree of confidence that the products we manufacture will continually meet customer expectations and regulatory requirements.”
 
With an initial focus on acute respiratory infections including COVID-19, Flu A/B and RSV, Alveo’s agile and dynamic molecular sensing and diagnostic platform, be.well, can be adapted to detect a wide range of diseases, bacteria, and other pathogens that threaten public health, across all modalities.