Artificial Intelligence (AI) in medical devices

Artificial Intelligence (AI) in medical devices

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artificial intelligence
artificial intelligence
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Medical devices and the opportunities with Artificial Intelligence (AI)

Artificial Intelligence (AI) already plays a role in our daily lives, from voice recognition in consumer products  to clinical diagnosis. BSI has witnessed in the past few years the growth of AI in the medical device industry. As AI is growing towards becoming embedded in numerous products across multiple industries, it is increasingly vital that the regulatory system will be ready to ensure ethical and trustworthy applications of AI.

BSI is proud to be at the forefront of this innovation, and we are working to ensure we are future-ready to embrace Artificial Intelligence.

New EU AI Regulation

On 21 April 2021, the European Commission (EC) published a proposal for a regulation governing artificial intelligence (AI). This new regulation offers BSI the opportunity to broaden its notified body presence offering by expanding into other core strategic sectors.

2022 will bring an exciting new dimension to our business as we work to establish an artificial intelligence EU notified body.

The Regulatory Services Division of BSI is currently working towards designation as an AI notified body to deliver product certifications. The AI notified body will focus around:

  • Certification of high-risk AI products that require notified body oversight.
AI notified body

EU Notified Body for AI

As a provider of AI, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market. For the EU, these are published in the proposal for a regulation governing artificial intelligence (AI). It is critical that you keep up to date with regulatory developments. Please look out for further information.