Individual engineers
Senior engineers with regulated-software expertise who slot into your existing teams and ceremonies.
Partner dev teams
Staff Augmentation
MedTech software engineers and dedicated development teams that ship under an ISO 13485-certified QMS — embedded into your organization, your tools, and your submission timeline.
Dedicated teams
Cross-functional pods — engineering, QA/V&V, and documentation — delivering as one unit under your roadmap.
Regulated by default
Everyone works to IEC 62304 and ISO 14971 discipline: traceability, test-first, DHF-ready output.
Flexible engagement
Scale up for a submission push, scale down after — without losing institutional knowledge.