Conventional eQMS platforms are document repositories with a workflow layer bolted on top. With AgentiQMS, 20 specialized AI agents run your QMS processes themselves — from intake to PSUR — thinking in processes, not forms. At every step: Human-in-the-Loop by design — the agent prepares, the qualified expert releases.
Our architecture models the QMS value chain — aligned with ISO 13485, FDA QMSR / 21 CFR 820, MDSAP and comparable frameworks — not a document repository. Every agent owns its process with inputs, outputs and accountability. Documents are a byproduct, not the centerpiece.
20 agents work alongside your team: pre-filling, escalating intelligently, answering SOP questions. HITL by design — the human decides, the agent supports.
No "AI feature" as an afterthought. Every agent is AI: root cause analysis, reportability classification, literature monitoring, compliance checking — woven into the platform logic from the ground up.
AgentiQMS adapts to your starting point — whether you currently run an established eQMS, are planning to introduce a new system, or operate without a dedicated QMS tool today. Three ways to bring the agentic architecture into your organization.
AI agents work on your existing systems — eQMS, ERP, MES, PLM, SharePoint or shared drives.
The full platform — as a greenfield QMS or replacement of existing systems.
A blend of Layer and Platform — for change support, learning, or pilots.
Conventional eQMS vendors built a document management system in the 2000s and bolted workflows on top. We start where quality actually happens: in the process.
20 specialized agents in an event-driven system. Every agent communicates via the central Event Bus. Click an agent to see its role. Use "Run Full Audit" in the AI QMS Auditor Demo tab to simulate how the auditor agent detects gaps in the ISO 13485 process landscape in real time.
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Every module takes administrative, documentation and follow-up work off your team's hands. That creates measurable FTE capacity, directly reduces cost — and makes the entire audit world fully visible for the first time.
AgentiQMS transforms not only processes — it changes how your entire quality organization operates.
Less firefighting. Less documentation. Less chasing. Teams focus on judgment, not data entry — retention improves, and so does team morale.
Your most experienced people stop being clerks. They drive quality decisions based on AI-prepared evidence — exactly the work they were hired for.
When CAPAs close faster, product teams move faster. Quality goes from bottleneck to driver of speed-to-market.
Build real AI competency into your quality organization now — before your competitors do. Lead the transformation instead of reacting to it.
In most MedTech companies, the visible quality costs are only the tip of the iceberg. The DeFeo/Juran framework quantifies the true Cost of Poor Quality (COPQ) — and shows exactly where AgentiQMS intervenes.
A company with €2M in tracked quality cost almost certainly sits on €30M–€50M in true COPQ. This gap is the economic playing field on which AgentiQMS operates.
Every stage a defect passes through multiplies the cost of resolution by ~10. AgentiQMS intervenes at the cheapest point: prevention.
Continuous process monitoring, a living risk model, controlled documents, and early competency and change assessment — defects are prevented before they occur. SOPs checked against reality, every day.
Automated intake, 100% QMS coverage, Layer-1 inline validation, and supplier/equipment trending replace manual sampling — faster, more complete, fully auditable.
CAPAs closed faster, NC with clear disposition, PSUR cycles without panic, risk files updated in real time, field findings structurally fed back. Internal failures cost less and last shorter.
Fewer field complaints missed, faster CAPA closure, no regulatory surprises. Recalls, vigilance events and enforcement actions are prevented upstream — through the orchestration of all agents.
MedTech demands validatable software. AgentiQMS is not only validatable — it validates itself continuously. Architecture, methodology and triggers are discussed in the context of a project inquiry.
An architecturally independent watchdog that continuously monitors the platform and reacts to relevant changes. A level of automated AI oversight that comparable LLM-based platforms in regulated environments rarely provide today.
Multiple stages with different time horizons — from inline checks to event-driven revalidations. The watchdog runs architecturally independent of the watched agents.
Inline check of every agent output before it reaches the user or downstream systems — before anything takes effect.
Periodic, independent regression runs against versioned, QA-approved reference datasets. Produces a signed audit trail with ALCOA+-compliant retention.
Reacts to relevant changes on the platform with appropriate revalidation depth — from partial cycles up to a full requalification.
Every agent output is routed into one of four bands based on its confidence. Routing is not configurable — it is hardwired at the system level. Concrete thresholds are explained in detail in the context of a project inquiry.
The technical substance of validation is active on our side and established under external audits (SOC 2 / ISO 27001). The MedTech-specific documentary layer (signed IQ/OQ/PQ protocols, VMP, IEC 62304 classification, Part 11 e-signature integration) is by design produced jointly with your validation team. The manufacturer owns the signatures, we provide the evidence — the way MedTech validation is supposed to work.
MedTech data is regulatorily and commercially sensitive. AgentiQMS is built for European hosting, regional residency, encrypted transmission and storage, and five-year tamper-evident retention — all proven under external audit.
Established ISMS for change management, access control, encryption, audit logging, risk management.
CertifiedAnnual audit for security, availability, confidentiality. External attestation of controls.
CertifiedEU data protection requirements fully implemented: DPA, processing record, DPIA-ready, subprocessor list.
CompliantArchitecture outside Annex-III high-risk via HITL-by-design and the exclusion of autonomous clinical decisions.
By DesignNot locked to any single AI provider. The best available models are integrated; every switch is fully revalidated by the Watchdog. No lock-in risk.
By DesignData stays in the customer's region. No cross-region replication without explicit consent. Encryption at-rest (AES-256) and in-transit (TLS 1.3). 5-year ALCOA+ retention. Hosted on AWS under SOC 2 / ISO 27001 audit.
🔒 Your data is never used to train AI models.
Full support from pilot through go-live and beyond. You get a team that knows your industry, your processes and the regulatory expectations.
Full support from Phase 0 to go-live. IQ/OQ/PQ protocols are co-authored with your validation team.
Structured onboarding for your QA, RA and operations teams. Every agent explained, every interface documented.
Continuous support, module updates and regulatory adjustments. No sales pressure after contract — partner, not vendor.
Your ideas feed into platform development. Additional modules are possible — you shape the path.
Tell us briefly what you're working on — we'll get back to you as soon as possible with a proposal for a 30-minute call or a live demo. No obligation, no sales pressure.
Executive Partner — MedTech & Strategic Accounts
1. We get back to you as soon as possible.
2. Short discovery call (30 min).
3. Tailored demo or pilot proposal.
Under NDA on request. Your data does not leave the EU (or the US — depending on your region).