Artificial Intelligence in Medical Devices

Are you thinking about including an artificial intelligence module in your medical device? Does your medical device already contain an artificial intelligence module? We can help you throughout all stages of your product’s life cycle, from conception to certification and maintenance.

Do you want to launch your medical device on the market in accordance with the requirements of Artificial Intelligence in Europe (MDR/IVDR and AI Act) and/or the FDA?

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Joint Innovation Project

We partner with companies involved in innovation projects, providing regulatory consulting, ensuring design quality from conception, as well as verification & validation, and certification tasks.

Regulatory Framework Consulting

We help define the regulatory strategy to follow and accompany you throughout the certification process.

AI implementation consulting

We offer consulting services for implementing artificial intelligence in your medical device. We help you select the algorithms that best meet the intended use of your device.

V&V medical device containing AI

SQS offers a specialized service in the validation of artificial intelligence systems applied to medical devices, ensuring their safety, efficacy, and regulatory compliance. Through rigorous methodologies and technical evaluations, we ensure that AI-based solutions meet the highest standards of quality and reliability for integration into clinical environments.