Of course AI can write code. But who's helping you ship your regulated product? There's a canyon between code and delivery, filled with compliance, verification, audits, security, and most importantly accountability to outcomes. While others are prompting, we're building bridges across that canyon. Bridges that carry production systems, not prototypes.
We're not just consultants advising you from the sidelines. We build and operate our own regulated software products like Opsfolio for compliance, Medigy for healthcare and surveilr for data engineering. We've walked through FDA submissions, FedRAMP authorizations, and HIPAA audits ourselves so we know we can do it for you.
Your bridge is built by people who cross it every day.
Our homegrown Opsfolio, surveilr, Medigy, Spry and other tools are all battle-tested in regulated environments
We've filed FDA submissions and navigated federal authorizations
We run production systems daily—we know what survives inspection
We treat every engagement like building a venture—because your success is our investment. End-to-end capabilities from ideation to market.
Strategic discovery & opportunity analysis
Technical blueprints & compliance mapping
User-centered experience design
Agile development with AI augmentation
Comprehensive quality assurance
Verification, validation & regulatory
Deployment, monitoring & support
Launch strategy & market entry
Four integrated service pillars designed for organizations navigating complex regulatory requirements
Full-stack engineering for regulated industries
Navigate FDA, HIPAA, NIST & FedRAMP with confidence
Extend your enterprise with intelligent automation
Expert-led data hygiene and evidence preparation for regulatory submissions
Deep domain expertise in the most demanding regulated environments
Digital health platforms, medical device software, EHR integration, and telehealth solutions built for FDA and HIPAA compliance.
Secure citizen services, federal compliance systems, and mission-critical applications meeting NIST and FedRAMP requirements.
Accelerating pharmaceutical R&D, rare disease research, and clinical trials with compliant data infrastructure and AI-powered insights.
Trusted by leading organizations in healthcare, government, and life sciences
When AI can write code, the hard part isn't the code—it's everything else
FDA, HIPAA, NIST, FedRAMP—we speak the language of regulators
Mission-critical systems that work when it matters most
SOC2 certified practices baked into every engagement
Complete traceability from requirement to deployment
Every decision documented, every change tracked
Code that lasts, not just code that ships
Architecture that grows with your success
We own outcomes, not just deliverables
FDA requires documented evidence that medical devices minimize use errors. Our human factors engineering services help you design safer devices and prepare compliant submissions.
Design to minimize use errors that cause harm
All 8 sections of HF submissions
Formative and summative testing
Per FDA guidance categories