About Qualtech

Building the Immune System for Modern Industry.

We didn't start in a garage. We started in the FDA's crosshairs—building risk infrastructure for Class III medical devices where failure means liability, recalls, and lives on the line.

That crucible forged something useful: a system that treats compliance not as bureaucratic overhead, but as the architecture of velocity. Good brakes let you drive faster.

01 // SYSTEM_CONFIG

The parameters that define how we build.

/etc/qualtech/values.conf

01TRUTH_MODE="BINARY"

# Compliant or Non-Compliant. Pass or Fail. There is no gray area in high-stakes industries.

02GOVERNANCE_EFFECT="VELOCITY"

# Good brakes allow you to drive faster. Rigorous risk management is a competitive advantage, not a burden.

03STANDARD_SCOPE="UNIVERSAL"

# Built for ISO 13485. Ready for AS9100, IATF 16949, SOC2, and everything else. Risk is risk.

02 // ORIGIN_LOG

2019::THE ORIGIN

Qualtech was born to solve data fragmentation in Medical Devices—the hardest regulatory environment on earth. FDA Class III. ISO 13485. Life-or-death consequences for every decision. We cut our teeth where failure isn't an option.

2024::THE EXPANSION

Risk is universal. Whether it's a surgical robot or a banking algorithm, the failure modes are identical. We built the Agent to solve them all. If our system can handle FDA Class III, it can handle SOC2, Automotive, or Aerospace standards in its sleep.

03 // THE_ARCHITECTS

MedTech quality veterans. Ex-Google engineers. We've lived the pain we're solving.

Mike Barile

Founder & CEO

Ex-Google, ex-Uber repeat founder. Previously led product at Sequoia-backed nCent Labs. Built search features at Google that drove tens of millions in revenue. Now building the infrastructure for enterprise risk.

Adam Martin

Lead Engineer

Full-stack architect with deep expertise in AI/ML systems. Translates complex regulatory requirements into elegant, scalable software.

Michael Barile

Advisor

30+ years in MedTech quality and regulatory affairs. Former VP of Quality at multiple FDA Class III manufacturers. The domain expert behind our compliance engine.

John Groves

Advisor

Enterprise software veteran. Advisor to multiple B2B SaaS companies on go-to-market strategy and scaling operations.

Armin Torres

Advisor

Operations excellence leader with experience across Aerospace, Defense, and Automotive. Brings real-world manufacturing insights to our platform.

Andrew Snow

Advisor

Seasoned executive with deep expertise in high-stakes industries. Guides our strategic expansion into new verticals.

Tyler Snell

Advisor

Technology strategist focused on enterprise AI adoption. Helps shape our product roadmap and market positioning.

04 // NEXT_STEPS

Ready to deploy the Universal Risk Agent?

Join the engineering teams who've stopped gambling with their products. See what battle-tested compliance looks like.

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