About Me
Welcome, Healthcare Technology and Security Enthusiasts!
I’m a globally experienced Healthcare IT Executive with over 25 years of hands-on leadership in digital health, cybersecurity, and regulatory compliance. My work spans more than 40 countries, where I’ve helped organizations bring innovative, secure, and compliant healthcare technologies to market.
Bridging Regulatory Knowledge with Technical Execution
What sets me apart is my ability to translate complex regulatory requirements into practical, technical solutions. I don’t just understand the regulations—I apply them directly to product design, development, and deployment.
I have deep, working knowledge of global regulatory frameworks such as:
FDA 21 CFR Part 820 & Part 11
EU MDR / IVDR
ISO 13485, ISO 14971, ISO/IEC 27001, ISO/IEC 81001-5-1
IMDRF cybersecurity guidance
Health Canada, TGA, and other regional authorities
Using this expertise, I’ve led the implementation of secure software development lifecycles (SSDLCs), risk management frameworks, and post-market surveillance programs that meet both regulatory and technical standards.
What I Do
Cybersecurity by Design: I lead a global Product Security Program that embeds cybersecurity into every stage of the product lifecycle—from architecture and coding to validation and monitoring.
Regulatory-Driven Engineering: I guide R&D and engineering teams to build compliant-by-design products, ensuring that security, privacy, and safety are not afterthoughts but core design principles.
Global Standards Leadership: I contribute to international working groups shaping the future of medical device cybersecurity and health IT interoperability.
Strategic Advisory: I help organizations evaluate technology strategies, conduct due diligence, and perform regulatory and security assessments.
Public Speaking: I deliver keynotes and expert talks on digital health innovation, cybersecurity, and regulatory transformation.