Compliance,
Automated
AI-Powered Quality Systems for Medical Device Manufacturers
Who This Is For
Small medical device and life-science manufacturers who are drowning in compliance paperwork
You're passionate about developing life-changing technology. But between FDA submissions, design controls, CAPA workflows, and traceability requirements, you're spending more time documenting than innovating.
You know your current system won't scale. Manual documentation creates bottlenecks. Quality fire-fighting is the norm. And every audit feels like a high-stakes bet.
"True innovation in medical devices isn't just about the technology—it's about building systems that let breakthrough ideas reach patients faster, safer, and more sustainably."
What To Expect
Real Results, Not Vaporware
AI-powered workflows that generate compliant documentation automatically as your team works. No more manual transcription or duplicate data entry.
Live dashboards showing exactly where every project stands, which CAPAs need attention, and what's blocking your next release.
Accelerate time-to-market by eliminating documentation bottlenecks and streamlining review processes.
Complete traceability and instant access to all required documentation. Walk into any audit with confidence.
Layers on top of your existing systems—no rip-and-replace. Works with your current tools and processes.
Systems that grow with you. From single product to full portfolio without exponentially increasing overhead.
Our Process
How We Work Together
Discovery & Assessment
We audit your current quality system, identify bottlenecks, and map your compliance requirements. No cookie-cutter solutions.
Custom Workflow Design
We design AI-powered workflows tailored to your products, team size, and regulatory pathway. Integration with your existing tools.
Implementation & Training
Phased rollout with hands-on training. Your team learns the system while we handle the heavy lifting.
Continuous Optimization
Ongoing monitoring, refinement, and support. We evolve the system as your business grows and regulations change.
Your Results, Guaranteed
We guarantee 2X ROI in 12 months or we'll keep working for free until you get the results you want.
We're confident in our approach because we've seen it work time and again. If we don't deliver measurable value—faster releases, reduced overhead, or audit-ready operations—we'll continue supporting you at no additional cost until we do.
Frequently Asked
Questions
Typically 6-12 weeks depending on your system complexity and team size. We use a phased approach so you start seeing value within the first month.
No. Our AI workflows layer on top of your existing systems—whether that's a modern QMS platform or a collection of spreadsheets. We integrate, not replace.
We monitor regulatory changes continuously and update your workflows accordingly. That's part of our ongoing support and optimization.
Pricing varies based on your company size, product portfolio, and complexity. We offer transparent, value-based pricing with ROI guarantees. Contact us for a custom quote.
We follow industry-standard security protocols including encryption, access controls, and regular audits. Our systems are designed with 21 CFR Part 11 compliance in mind.
Yes. Our workflows generate submission-ready documentation and traceability matrices. We can also connect you with regulatory consultants if needed.