AI automation and software for operations-heavy businesses.
I automate the manual, document-heavy work that eats your team's time. When your world is regulated or technical, I bring the engineering background to do it right.
- Production AI · a decade in regulated engineering
- Senior AI Engineer, enterprise healthcare
- AWS Certified
- ISO 13485 · regulated background
What I do
Let your team do the work only people can do.
Most businesses lose hours every day to manual, repetitive, document-heavy work. I build the AI and software that handles it for you, accurately and built to last.
AI Automation & Custom Software
The everyday work that drains operations teams, turned into reliable automated systems your people can trust.
Explore AI automation →- Document & workflow automation
- Custom knowledge bases over your docs
- Contract & document review
- Automated report generation
- BI dashboards & data pipelines
- Data-driven decision support
- API & system integrations
- Custom web apps & tools
Specialized expertise
When your industry is regulated or technical, I go deep.Regulated Healthcare AI
Automate the manual, document-heavy work that drains healthcare and pharmacy operations teams.
Learn more →Quality & Regulatory
ISO 13485 & 9001, FDA 21 CFR 820 (QMSR), design controls, risk/FMEA, CAPA, and eQMS, all accelerated with AI.
Learn more →Medical Devices
Design, prototyping, FEA, and verification & validation for Class I & II devices, from concept to production.
Learn more →Proof
Real systems I've built and shipped.
Designed, built, and delivered across three very different industries.
Operations automation
Document-heavy operational workflows like intake, review, and triage, automated with AI built to hold up under compliance scrutiny.
Regulated engineering
Implantable & surgical devices, a biomechanics test rig (50 to 100× faster testing), an instrumentation redesign (10× cost reduction), and an ISO 13485 system built from scratch.
Scottsdale Event Decor
A web app built on the QuickBooks API that runs inventory and event booking, and creates quotes, invoices & schedules automatically. One connected workflow from quote to paid, with no retyping between steps.
Want to see it working? Try the live AI demos at ai.gaengg.com →
How I build
Built with discipline, not vibes.
I build on Anthropic's documented AI-native software development lifecycle. The spec is the source of truth, version-controlled artifacts are the chain of custody, hooks act as deterministic gates, and humans stay accountable for judgment. What I add is the regulated-industry layer: mapping those gates to design controls, traceability, and the evidence an auditor expects.
- 01
Spec is the source of truth
Requirements and decisions are written, versioned, and enforced. Nothing important gets buried in a throwaway prompt.
- 02
Traceable & auditable
Every change traces back to a requirement and a recorded decision, so the audit trail is built in.
- 03
Gated, not optional
Pass/fail checks run before anything ships. That discipline maps directly to ISO 13485 and design controls.
Working together
Start small. Prove value. Scale.
A low-risk path from first conversation to running systems. You never commit to a big number cold.
- Step 1 · Free
Opportunity Call
A conversation to understand your process and find where AI would save you the most.
- Step 2 · Free
Quick Demo
I build a short demo on your own workflow, so you can see what AI would actually do for you.
- Step 3 · Fixed fee
Opportunity Audit
1 to 2 weeks mapping your workflows to concrete automations with ROI.
- Step 4 · Phased
Build
I build the solution to a defined scope and milestone plan, paid in phases.
- Step 5 · Monthly
Run & Improve
I operate, monitor, and extend the systems as a managed service.
About
I'm Gonzalo, a biomedical engineer turned AI engineer.
I spent a decade in engineering across medical devices, quality and regulatory systems (ISO 13485), healthcare data, and business software. My most recent years have gone into building and shipping production AI inside a large regulated healthcare organization: owning AI subsystems end to end, driving modernization efforts, mentoring engineers, and partnering with cross-functional leaders to lower costs, improve efficiency, and sharpen business insight.
That mix is rare. Most AI consultants don't understand regulated or technical environments; most people who do can't build production AI. I do both, and I lead every engagement personally, bringing in vetted specialists when a project calls for it.
Have a manual, document-heavy workflow that's eating your team alive?
Book a free opportunity call. We'll find where AI would save you the most, and then I'll build you a short demo on your own workflow. No pitch, no obligation.
Book a free call →