Cybersecurity engineers
Security architecture, threat modelling, secure development, verification and supported-lifetime governance.
Security engineering within medical-device safety and lifecycle governance.
Downloadable field guides
Security architecture, threat modelling, secure development, verification and supported-lifetime governance.
Articles
A playful but serious reflection on AI as assistant, reviewer and decision-maker—and why fluent answers still need evidence, judgement and accountability.
AI changes the speed and economics of medical-device development, but it does not remove the need for product definition, objective evidence, competent review or manufacturer accountability.
Why outsourcing medical-device development increases the need for intelligent manufacturer oversight—and what must be controlled before an audit or submission exposes the gaps.
Why absence of commercial registration does not automatically prevent a digital health technology from being used in a clinical trial—and the questions sponsors should ask instead.
How to integrate cybersecurity governance and evidence across the complete medical-device lifecycle.