Novigenix receives ISO 13485 Certification from BSI
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 as well as Michaël Brégand, Ariaq’s Expert & Partner in Life Sciences.”
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.”
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.
For interviews and additional information, please contact:
For Novigenix:
Claudia Ungarelli
claudia.ungarelli@leidar.com
+39 349.3807383
For Ariaq:
Joachim Fernandes
Joachim.fernandes@ariaq.ch
+41 79 689 34 90
About Novigenix
Novigenix pioneers AI-driven healthcare solutions, analyzing RNA data to personalize cancer treatments and improve patient outcomes. Leveraging molecular technologies and AI, Novigenix maps systemic immune responses, facilitating tailored therapeutic advancements based on individual immune response profiles.
For over a decade, Novigenix has demonstrated leadership in bringing precision immunology to the market, integrating multi-omics data with AI through its proprietary LITOSeek™ platform. This innovative approach offers insights into patient immune responses, driving precision therapy developments.
About ARIAQ SA
Ariaq SA is a training and consultancy organisation for quality and performance management in Switzerland. Its domain of expertise includes quality, health, safety, sustainability, Lean management, Supply Chain, Life Science and strategic transformation. As a leader, Ariaq is active in industry, services and public administration.
Ariaq can rely on a modern infrastructure, constantly updated teaching resources and, above all, a team of motivated and experienced trainer-consultants, all of whom have acquired over 10 to 20 years' practical experience in small to large-sized companies with local and international footprint.
