AI-Enabled Medical Device Development | FAQ Paper

Medical device manufacturers increasingly rely on Artificial Intelligence (AI) and Machine Learning (ML) to enhance device performance and patient outcomes. Successfully integrating AI requires early consideration of critical design, compliance, and risk management questions. Intertek's new guide, "Key Questions for AI-Enabled Medical Device Development," addresses essential factors including clinical problem definition, representative test data, transparency of AI decisions, cybersecurity, and model validation. Complete the form below to download your copy.