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Invitation Only
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Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

Martha De Cunha Maluf-Burgman, MBA

Director Regulatory Affairs - Digital Health - EMEACLA
Edwards LifeSciences, Netherlands

Mechanical Engineer with B. Political Sciences, MBAs in International Relations and Marketing Management (SUNY-USAL), and post-grade in (Tele) Communications Regulations. Brings over 29 years of experience in Telecommunications and Radio Spectrum Regulations, International, Institutional and Governmental affairs, Satellite regulations, and advocacy on Radiocommunications and wireless technologies, Telemedicine, eHealth, Artificial Intelligence, Interoperability and Cybersecurity, and In Silico technologies. With vast experience in ETSI (including SIG Securing AI), Bluetooth SIG, IEEE PHD Cybersecurity WG, AAMI, ENISA, etc. On top of official job, she is also innovator and inventor. In previous job at Medtronic as Regulatory Affairs Program Manager for Digital Health had responsibilities on Policy Intelligence & Advocacy in EMEA region on Digital Health including AI/ML, Cybersecurity, Interoperability, Data Sharing, etc. - Preserving responsibilities on Advocacy for Radio Frequency, Digital Health and In Silico technologies.
Currently working for Edwards Lifesciences as Director Regulatory Affairs-Digital Health, with strategic Advocacy responsibilities in EMEA, Canada and Latin America (EMEACLA) region. Leading the Transition Service Agreement RA EMECLA team serving ex Critical Care (today BD APM). Serving as strategic advisor, with focus on its Critical Care business unit (BD APM), and also advising THV, TMTT, Advance Technologies, the Computer Modelling & Simulation Team, and the Corporate Data Management organisation. Liaises with R&D, CISO & InfoSec on specific on cybersecurity regulations and standards and is member of the Corporate Regulatory Intelligence Council as subject matter expert on digital health. In partnership with Edwards’ CM&S Team, promotes internally the development and incorporation of in-silico clinical trials and digital twins. Edwards representative in MedTech Europe's Digital Health Committee: Data Governance (ex Co-Chair), Interoperability, AI and Cybersecurity WGs (ex Chair); MedTech Canada; AdvaMed Cybersecurity WG; MecoMed Digital Health Committee. Avicenna Alliance member as Leader of Policy Development Working Group advocating for acceptance of in silico evidence in the regulatory pathway.

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