ISO 13485:2016 is an internationally recognized standard for quality management systems in the medical device industry. Achieving this certification confirms that Novigenix meets stringent requirements for a comprehensive quality management system, ensuring reliability, traceability, and reproducibility in all its processes.

The rigorous journey to ISO 13485:2016 certification involves the implementation and meticulous documentation of a quality management system that touches every aspect of Novigenix’s operations. The training and consulting organisation Ariaq SA played a crucial role in this success, guiding Novigenix through the complexities of establishing and maintaining a robust quality management system covering all aspects of the business, including the Novigenix AI-RNA analytics platform LITOSeek™. Joachim Fernandes, Director at Ariaq SA,  said, “In all my years working with various companies who achieved ISO certifications, Novigenix stands out as an exceptional case. Passing the stage two audit with zero non-conformities is a rare and impressive feat. This achievement speaks volumes about the dedication, thoroughness and professionalism of the Novigenix team.”

Carlota Salgado, Head of Quality at Novigenix, commented, “Having the highest level of quality management systems in place reflects our unwavering commitment to excellence. This certification is an important milestone as we scale up our partnerships globally. Importantly, it also recognizes our culture of always seeking the very highest quality that permeates every level of our organization.”

Brian Hashemi, CEO of Novigenix, said “I want to thank the entire team at Novigenix that contributed to reaching this important milestone. This process has taken 18 months of hard work and I am very proud of the commitment of all our teams to adhering to the highest quality standards, providing assurance to our biopharma partners and to the patients for whom we develop cutting edge solutions. I also would like to thank Michaël Brégand, Ariaq’s Expert & Partner in Life Sciences, for his professionalism and excellence in quality to support us throughout this process.”

The successful implementation of ISO 13485:2016 certification highlights Novigenix’s position as a trusted partner in the biopharma sector, dedicated to advancing healthcare through innovative and reliable AI-enabled solutions.