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About us

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

Behind agentiQMS are people, not sales decks — a union of MedTech consulting, quality management expertise and AI engineering.

Mission
Quality management that relieves people — and protects patients.
Vision
A world where AI makes quality more reliable — not riskier.
What we stand for

Three convictions that drive us every day.

01
Human-in-the-Loop

The AI prepares, the qualified human decides. Trust comes not from autonomy, but from control.

02
Process before document

Quality happens in the process, not in storage. Documents are outputs — not an end in themselves.

03
Validation as a constant state

Validation is not a one-off project but a continuous, evidenced state.

Team

Two minds. One idea that grew.

agentiQMS grew out of 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.

Daniel Müller — Executive Partner for MedTech & Strategic Accounts at agentiQMS
Daniel Müller
Executive Partner — MedTech & Strategic Accounts

The originator and initiator of agentiQMS. From his work at Crew8 he knew the recurring problems of MedTech companies: QM staff drowning in documentation and administration instead of focusing on their actual expertise. He set out to find an AI-based answer.

A business-information-systems engineer with a long-standing AI focus and over nine years of MedTech industry depth. agentiQMS emerged from combining market observation with the domain knowledge of several MedTech specialists — led together with Uwe.

Emailcrew8.deLinkedIn
Uwe Gölz — QM & AI Concept Lead at agentiQMS
Uwe Gölz
QM & AI Concept Lead

Co-developer of the agentiQMS concept. He brought the substantive expertise and the concrete MedTech use cases — without which the agent concept would be only a technical shell. He makes sure each of the 17 agents works in a regulatorily sound and process-sensible way.

Decades of MedTech quality expertise — from CAPA remediation and post-market surveillance to audit readiness and cost-of-poor-quality analyses, the economic basis of our ROI model. Through his consultancy QUALYMENTOR he also guides medical-device companies on a risk-based, results-oriented basis.

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Together

agentiQMS is built by three specialized houses.

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

Strategy & MedTech Market

An HR strategy consultancy and executive-search boutique with a strong MedTech focus (over nine years of industry experience). It guides companies in strategic HR development, fills key roles — and secures agentiQMS’s constant user and industry perspective.

crew8.de →
Quality Management

Specialized MedTech quality consulting focused on CAPA, PMS, audit readiness and cost of poor quality. Risk-based, hands-on, results-oriented. The partnership ensures every agentiQMS agent works in a regulatorily sound and process-sensible way.

qualymentor.com →
Platform & AI Engineering

Builds agentiQMS as a specialized AI and automation platform and contributes 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 →
Get to know us

Let’s talk about your QMS strategy.

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