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About

We're building the next generation
of the Quality Management System.

AgentiQMS is built on the conviction that AI and digitization are not a "nice-to-have" for MedTech organizations — they are the decisive lever to sustainably advance product quality, patient safety and medical progress. We bring together medical-device quality expertise and modern AI engineering practice.

Mission

Quality management that frees people — and protects end users.

We want to relieve MedTech organizations from the administrative burden of quality management — and at the same time make them more compliance-safe than they could be with document management systems.

Our clients' employees should focus on decisions, not forms. Our clients should get to market faster with less risk. And our clients' end users — operators, clinics and patients — should benefit: through higher product quality, greater safety and faster technological progress in MedTech.

Vision

A world where AI makes quality more reliable — not riskier.

We believe in the immense opportunities AI and digitization open up for MedTech — economically, regulatorily and most importantly clinically. But we also believe: in regulated industries, AI is only progress when it stays auditable, validated and under human control.

Our vision is a MedTech industry where AI agents handle routine, qualified people make decisions, and the results are trustworthy for patients and authorities alike. The industry becomes more productive, safer and more innovative — simultaneously.

What we stand for

Three convictions that drive us every day.

Patient safety as the benchmark

Every module, every agent, every architectural decision is ultimately measured by whether it leads to better product quality and patient safety — not just more dashboards.

Free people, don't replace them

Our agents work with the qualified expert, not against them. HITL by design — the agent prepares, the human decides.

Accelerate progress in MedTech

When QMS overhead drops, better therapies reach patients faster. That is the real societal value of what we do.

Team

Two minds. One idea that grew.

AgentiQMS emerged from the meeting of two complementary worlds: years of MedTech market observation and strategic AI understanding met deep quality management practice and concrete use-case experience.

Photo to follow Daniel Müller
Daniel Müller
Mentitech
Executive Partner — MedTech & Strategic Accounts

Originator and initiator of AgentiQMS. Through his work at Crew8 he knew the recurring problems MedTech firms face: QA people who drown in documentation and administration instead of focusing on their actual expertise. He set out deliberately for an AI-based answer.

Business informatics background with a long-standing AI focus and over nine years of MedTech industry depth. AgentiQMS emerged from the combination of market observation and the domain expertise of several MedTech specialists — led together with Uwe.

Photo to follow Uwe Gölz
Uwe Gölz
Mentitech
QM & AI Concept Lead

Co-architect of AgentiQMS. Brought in the substance and the concrete MedTech use cases without which the agent concept would only be a technical shell. Ensures that every one of the 20 agents works in a regulatorily sound and procedurally sensible way.

Decades of MedTech quality expertise — from CAPA remediation and post-market surveillance through audit readiness to cost-of-poor-quality analyses, the economic foundation of our ROI model. With his consultancy QUALYMENTOR, he supports MedTech companies in parallel: risk-based, results-driven.

In the network

AgentiQMS is built by three specialized houses.

Mentitech as platform and AI engineering lead, in close cooperation with Crew8 (strategic MedTech consulting and market access) and QUALYMENTOR (deep quality management expertise).

Mentitech
Platform & AI Engineering

Mentitech

Builds AgentiQMS as a specialized AI and automation platform and brings the technological substance: agentic architecture, AI models, Validation Watchdog infrastructure, data integrations and platform engineering. Mentitech also develops decision-intelligence and automation products for regulated industries.

mentitech.com →
Crew8
Strategy & MedTech market

Crew8

HR strategy consultancy and executive search boutique with strong MedTech focus (over nine years of industry experience). Supports companies on strategic HR development, fills key roles — and secures AgentiQMS's continuous user and industry perspective.

crew8.de →
QUALYMENTOR
Quality Management

QUALYMENTOR

Specialized MedTech quality consultancy focused on CAPA, PMS, audit readiness and cost of poor quality. Risk-based, hands-on, results-driven. The cooperation ensures every AgentiQMS agent is regulatorily sound and procedurally sensible.

qualymentor.com →

Ready for a concrete demo?

30 minutes — we'll show the platform, hear about your starting situation, and propose a fitting next step. No obligation.

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