Aligning AI, Software & Cybersecurity Compliance Strategies to Reduce Regulatory Gaps in Connected Medical Devices

• Understanding the critical differences and overlaps between MDR, AI Act, product cybersecurity and information security requirements to develop a more holistic compliance strategy for AI-enabled and connected medical devices
• Establishing cross-functional approaches to harmonise regulatory, cybersecurity and software development activities and reduce the risk of late-stage compliance issues that delay market access
• Preparing for the next generation of digital health technologies, including AI, synthetic data and digital twins, while ensuring products remain compliant with evolving European regulatory expectations

Speakers:

Martha De Cunha Maluf-Burgman

Director - Regulatory Affairs

Edwards Lifesciences