IEEE SA Cybersecurity for Medical Device Certification
In this THMT ConV2X podcast interview, Maria Palombini, MBA, Director of Healthcare & Life Sciences Global Practice Lead at the IEEE Standards Association (IEEE SA), shares how
the Cybersecurity for Medical Device Certification Program (IEEE 2621) is helping manufacturers, startups, regulators, and health systems align to globally recognized cybersecurity standards—by design, not as an afterthought.
Together with Alex Romanovich, Founder & CEO of Global Edge Markets, Ms. Palombini unpacks why a security first mindset is
essential for the future of digital health.
The podcast explores:
✔ Why the rapid growth of connected medical technologies has intensified cybersecurity risks
✔ How certification strengthens trust in connected medical technologies
✔ How IEEE’s consensus
driven standards help developers build security in from the start
✔ The role of cybersecurity device certification in streamlining regulatory pathways
✔ What a trusted, interoperable connected care ecosystem could look like by 2030
✔ Why globally aligned standards matter for regulatory and market
readiness
Full public access at
DOI: https://doi.org/10.30953/thmt.v10.652
Learn more about the program: ieeesa.io/medicaldevice
View the Cybersecurity for Medical Device Certification video here.
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