Novigenix, a leader in AI-driven healthcare solutions, successfully achieved ISO 13485:2016 certification, passing the Stage II audit with zero non-conformities. This milestone underscores Novigenix’s unwavering commitment to the highest standards of quality in providing solutions for the biopharma industry.
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.
