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

The number of FDA authorisations of AI-enabled software as medical devices (SaMDs) has accelerated over the past three years. Today many scientists and engineers are exploring the possibilities of using AI to enhance their existing products and develop new ones. 

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

This whitepaper, the second in our series of three, offers best practice guidelines for medical device developers considering how to integrate AI into their products. 

Download our whitepaper to learn how to:

• Choose an appropriate AI model
• Develop and test model data
• Identify and avoid AI model biases
• Gather and manage your training data
• Plan your FDA pre-submissions