Product and application security for regulated medical software. I write the cybersecurity documentation that a medical device has to bring to a regulator.
I'm a QA/RA & Security Specialist at Hermes Medical Solutions, where I author the product cybersecurity evidence that goes into regulatory submissions — threat models, security risk assessments and the premarket security documentation itself — inside an ISO 13485 quality system, against IEC 81001-5-1 and FDA premarket cybersecurity requirements (FD&C Act section 524B). The role also covers EU AI Act readiness.
Current focus areas
- Premarket cybersecurity for medical software (FDA 524B, IEC 81001-5-1)
- Security risk management and threat modeling across the product lifecycle
- Supporting market clearance for medical devices (FDA 510(k), EU MDR)
- Application security — secure SDLC, SAST/SCA and CI/CD hardening (OIDC workload identity) for regulated software
Technical skills
Windows Server, Unix/Linux, Docker, Kubernetes, PowerShell, Bash, Python and Git
I care about making healthcare technology safer and more trustworthy — protecting patients by making sure the software inside their care is secure by design.
This site is itself a work sample — its content-security policy, CI gates and supply-chain posture are documented in the repository.