Developing AI in software as a medical device (SaMD):

The number of FDA authorisations of artificial intelligence medical devices and AI-enabled software as medical devices (SaMDs) has accelerated over the past three years. 

Today many scientists and engineers are exploring how AI in medical devices and machine learning medical devices can enhance their existing products and develop new ones.

The right medical device AI model and data can transform healthcare, helping physicians and patients to identify symptoms, diagnose and manage conditions. Developing these technologies and gaining regulatory approval requires strategic oversight and informed decision-making.

This whitepaper, the second in our series of three, offers best practice guidelines for medical device developers integrating AI for medical devices into their products.

Download our whitepaper to learn how to:

• Choose the most suitable AI model for your AI-based medical devices
• Develop and test model data within strong medical device quality systems
• Identify and minimise AI model biases across software in a medical device
• Gather and manage reliable training data for regulatory strategy medical devices
• Plan effective FDA pre-submissions and meet 510(k) AI software expectations