Designing the future

AI is transforming many aspects of life today, including healthcare and medical devices. This whitepaper, the third in our series on AI-enabled software as a medical device (SaMD), examines how regulatory agencies are responding to the rapid proliferation of AI-enabled SaMDs. 

Regulators are adapting existing submissions processes and introducing new requirements and medical device developers must be prepared to engage early to optimise their submissions’ chances of success. 

Download the whitepaper to read about current regulatory practices for AI-enabled SaMDs in key regional agencies. With a particular focus on FDA guidelines, this whitepaper also considers the European Union’s AI Act, MDR/IVDR regulations and the UK’s MHRA response. We explore current FDA authorisation trends and anticipate future developments for this promising new technology.

Learn how to:

• Understand FDA Pre-Sub expectations and avoid common pitfalls
• Navigate diverging global requirements for AI-enabled SaMD
• Anticipate the evolution of risk classification of algorithms for detection, triage, diagnosis and treatment-planning
• Prepare for the next generation of multimodal and personalised AI medical systems