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Antonina Burlachenko, Head of Quality and Regulatory Consulting, brings 13+ years of expertise in software development for regulated medical products. Skilled in quality assurance, project management, and innovation, she drives excellence through her deep knowledge and goal-oriented approach.
The ISO standard’s harmonized structure aligns seamlessly with other management system standards like ISO 27001 (information security) and ISO 9001 (quality management). This alignment simplifies integration by allowing organizations to use common frameworks and processes. It reduces duplication, streamlines compliance efforts, and enhances operational efficiency, saving time and resources while improving consistency across various management domains. Organizations benefit from a unified approach to governance, risk management, and process improvement.
The standard effectively balances the need for safety and the push for innovation by providing a structured approach to managing risks associated with AI systems. While it may not delve deeply into specific safety measures, its guidance ensures organizations can develop cutting-edge technologies responsibly. This enables organizations to foster innovation while maintaining ethical practices, regulatory compliance, and stakeholder trust, ensuring that technological advancements are safe and sustainable.
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