Medical devices and the opportunities with Artificial Intelligence (AI).
The integration of AI into medical devices brings transformative potential to healthcare, improving patient outcomes and creating new possibilities for diagnostics and treatment.
However, it also introduces new risks and increased regulatory scrutiny. As AI continues to evolve, manufacturers must remain proactive in adapting their compliance strategies.
By staying informed and compliant with the applicable regulations, AI-enabled medical device manufacturers can contribute to the future of healthcare.
BSI is an accredited AI Management System Certification Body recognized by Raad voor Accreditatie (RvA) and is currently working towards designation as an AI Notified Body.
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