Vadum

Software & Device Engineering+Compliance Infrastructure

Services

Software & AI

Custom software solutions, AI/ML integration, architecture review, and technical strategy for med-tech and regulated industries.

Device Development

Hands-on medical device engineering — from component selection and sensor assembly through benchtop characterization, wet lab validation, and ML-driven calibration.

Engineering
ProcurementSystem DesignOpticsAssembly
Testing
Benchtop V&VWet LabBioprocess
Lifecycle
Signal ProcessingML CalibrationEOL Statistics

Regulatory & Compliance

Seven years and 7 FDA submissions — building the software and documentation that goes into the filing, not advising from the outside.

Products
SaMDClass III Devices
Submissions

Products

Coming Soon

Chirograph

AI accelerates output while compressing headcount. Verification can't keep up. Chirograph closes the gap.

About

Vadum is built on seven years of hands-on FDA-regulated product development — Class III device software, sensor systems, clinical data infrastructure — across 7 submissions. Before founding Vadum, I took devices from early prototype through benchtop characterization, wet lab validation, ML calibration, and clearance. I've also stepped into products mid-cycle — rearchitecting software and swapping core subsystems without resetting active R&D and V&V timelines. I don't consult from the outside. I write the software, integrate the hardware, run the validation, and produce the deliverables and documentation that the FDA accepts. One point of contact from bench to submission — no handoffs, no gaps between engineering, regulatory, and the lab.

Matt Slipenchuk, Founder

Contact

Have a project in mind? Let's talk.