I ship compliant, audit-ready medical device software.
Researching how AI agents can enhance end-user experience within ISO 13485, FDA QMSR, HIPAA, ISO 27001 guardrails.
Regulated delivery
Own the full lifecycle across QMS, verification & validation, release management, and post-market monitoring—so teams move fast without breaking compliance.
Audit-first UX
Design interfaces that surface evidence, rationale, and handoffs in-line, making reviews faster for clinicians, auditors, and stakeholders.
AI agent prototypes
Prototypes are built with consent, logging, and reviewer handoffs.
Operating model for AI in regulated products
Practical guardrails, reviewer workflows, and measurement frameworks that keep cross-functional teams aligned.
- Map risk controls directly to ISO/FDA guidance.
- Make agent↔human handoffs traceable and reviewable.
- Close the loop with post-launch monitoring and drift alerts.
Latest note
The first essay launches on Substack soon — systems thinking, templates, and realistic guardrails. Subscribe to get frameworks and walkthroughs as they drop.
Coming soon on Substack
The first essay launches on Substack soon — systems thinking, templates, and realistic guardrails. Subscribe to get frameworks and walkthroughs as they drop.