Selected work

Delivery in regulated environments

End-to-end product management for MedTech and enterprise platforms—spanning discovery, build, V&V, and scalable launches. Each engagement balances user experience, regulatory guardrails, and measurable outcomes.

Case briefs (representative, anonymized)

Representative, anonymized briefs highlighting delivery across regulated environments.

iPad audiometry under QMS

Context: Occupational hearing-testing app with clinician + patient flows
Constraints: ISO 13485, HIPAA; patient privacy; audit-ready delivery
Challenge: Introduce patient notifications without weakening traceability
Approach: Consent-by-design, V&V, DHF/DMR updates, staged rollout, post-market monitoring
Outcome: Faster reviews while preserving evidence requirements

Details anonymized; deeper artifacts on request.

Enterprise compliance dashboard

Context: Web portal for multi-site enterprise customers
Constraints: ISO 27001 controls; role-based access; exportable records
Challenge: Give site-level visibility with audit-defensible evidence
Approach: Role models, evidence links, filterable status, exportable reports
Outcome: Quicker compliance checks and clearer stakeholder communication

Details anonymized; deeper artifacts on request.

SSO enablement at scale

Context: Multi-org enterprise deployments
Constraints: SAML/OIDC; signing-certificate lifecycle; change control
Challenge: Reduce onboarding friction while maintaining governance
Approach: Standardized SSO runbook, certificate rotation, environment segregation, rollback plan
Outcome: Predictable launches with a consistent risk posture

Details anonymized; deeper artifacts on request.

Deeper artifacts available on request. Contact