BSI issues over 50 AI Certificates driving trust and innovation

This is a clear demonstration of our commitment to advancing responsible Artificial Intelligence (AI).

Over 50 AI certificates have now been issued to MedTech organizations across diverse medical technologies, underscoring BSI’s leadership in setting trusted standards for AI development and deployment.

As AI technologies become increasingly integrated into everyday business operations and patients’ products, ensuring ethical, transparent, and secure AI systems is paramount. BSI’s AI certification process rigorously evaluates AI solutions against the applicable regulations and standards, focusing on safety, quality, transparency, and data security.

Reaching this milestone marks a pivotal step toward fostering greater confidence in AI technologies in the MedTech sector. Our certification process not only helps medical device manufacturers to demonstrate medical devices safety and compliance but also encourages innovation through responsible AI adoption.

The certified devices span a broad spectrum of medical technologies including in vitro diagnostic, software as medical device (SaMD), General and Active devices – highlighting the wide-ranging impact of AI.

This achievement underscores BSI’s commitment to supporting healthcare providers, manufacturers, and regulators in deploying AI that meets rigorous quality and ethical standards. BSI certification represents a mark of trust demonstrating that AI systems comply with stringent criteria for safety, quality and trustworthiness.

BSI continues to work closely with global experts and regulatory authorities to ensure compliant and ethical AI integration in medical devices keeping pace with rapid technological advancements.

To know more, visit our medical devices webpage.