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.
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.
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.
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.
Our agents work with the qualified expert, not against them. HITL by design — the agent prepares, the human decides.
When QMS overhead drops, better therapies reach patients faster. That is the real societal value of what we do.
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.
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.
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.
Mentitech as platform and AI engineering lead, in close cooperation with Crew8 (strategic MedTech consulting and market access) and QUALYMENTOR (deep quality management expertise).
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 →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 →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 →30 minutes — we'll show the platform, hear about your starting situation, and propose a fitting next step. No obligation.