Martha De Cunha Maluf-Burgman
Director - Regulatory Affairs Edwards Lifesciences
Martha De Cunha Maluf-Burgman is a Global Regulatory Affairs and Digital Health Leader with over 29 years of international experience across telecommunications and medical devices. She currently serves as Director, Regulatory Affairs – EMEACLA at Edwards Lifesciences. A subject-matter expert in Digital Health, AI, cybersecurity, SaMD/SiMD, radiocommunications, and in-silico technologies, she serves on the Avicenna Alliance Board and EDITH’s Virtual Human Twins Advisory Board, and leads Policy Development WG, UK CEiRSI, MDCG, and IMDRF initiatives. She is a RAPS-certified strategist, published co-author, inventor, and mentor.
Seminars
Wednesday 9th December 2026
Aligning AI, Software & Cybersecurity Compliance Strategies to Reduce Regulatory Gaps in Connected Medical Devices
11:30 am
- 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
