Industry
Regulated Industries
Enterprise integration and field-operations consulting for pharma, life sciences, and medical-device organizations.
What regulated buyers need
Audit trail, traceability, validation. Pharma and medical devices are both in our core experience.
What we ship
ERP + CRM + ops integration; cross-ecosystem where the buyer is multi-platform.
Medical Device Experience
FDA-validated software in the field — including 510(k) and clinical trials
10+ years of SDLC and software V&V for medical-device companies. Documented process discipline — IEC 62304-aligned SDLC, V&V, traceability — applied to every regulated engagement.
- 510(k) submissions
- FDA validation & approval
- Clinical trial software
- IEC 62304-aligned SDLC
- V&V + traceability
Domain experience: immunohematology, AI-assisted stroke detection, and other regulated diagnostic and treatment workflows.
Ready to talk?
Plain-spoken consulting for utilities, government, and field-service organizations.