Built for audits. Designed for people.
Every capability is designed around one goal: making quality management faster, simpler, and audit-ready from day one. Modules are organised around the regulatory processes you are audited on.
Explore each capability below to see how it works, what regulations it addresses, and how it connects to other modules.
Document Control
Every document tracked, every version controlled
Manage the full lifecycle of quality documents in one place. Configurable review and approval workflows ensure every SOP, work instruction, and form is reviewed and signed before it is used. No more chasing signatures or wondering which version is current.
How It Works
Draft a document, assign reviewers and approvers, and collect electronic signatures with meaning codes. Once signed, the record is edit-locked and any change needs a new revision. Previous versions are retained with the full audit trail.
Key Capabilities
Regulatory Standards Addressed
- ISO 13485 Section 4.2.4 — Control of documents
- FDA QMSR (21 CFR 820, incorporating ISO 13485:2016 §4.2.4) — Document control
- EU MDR Annex II — Technical documentation
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
CAPA Management
Find the root cause. Fix it permanently.
Corrective and preventive actions that actually prevent recurrence. Built-in investigation tools guide your team from identification through root cause analysis to effectiveness verification, with full traceability at every step.
How It Works
A quality event triggers a CAPA. You classify the issue, assign investigators, conduct root cause analysis with the built-in root cause analysis fields, define corrective actions with deadlines, implement changes, verify effectiveness, and close — all from one record. Every step is audit-logged with electronic signatures.
Key Capabilities
Regulatory Standards Addressed
- ISO 13485 Section 8.5.2/8.5.3 — Corrective and preventive action
- FDA QMSR (21 CFR 820, incorporating ISO 13485:2016 §8.3 and §8.5) — Nonconforming product, CAPA
- EU MDR Article 10(9) — Corrective actions
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Audit Management
Audit-ready at all times, not just before inspections
Plan, execute, and close audits with confidence. Whether internal quality audits, supplier assessments, or notified body inspections, every finding is tracked from observation through corrective action to closure.
How It Works
Create an audit program with a rolling schedule. For each audit, define scope, assign auditors, generate checklists from templates, record observations and findings during the audit, classify findings by severity, create linked CAPAs for critical findings, track corrective actions to closure, and generate the final audit report — all in one connected workflow.
Key Capabilities
Regulatory Standards Addressed
- ISO 13485 Section 8.2.4 — Internal audit
- FDA QMSR (21 CFR 820, incorporating ISO 13485:2016 §8.2.4) — Internal audit
- EU MDR Article 10(9) — Systematic procedures for review
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Risk Management
Identify, assess, and control risks throughout the product lifecycle
A complete risk management process aligned with ISO 14971. From hazard identification through risk estimation, evaluation, and control, to residual risk assessment and post-production monitoring. Every risk decision is traceable and audit-ready.
How It Works
Identify hazards and hazardous situations, estimate severity and probability of harm, evaluate risk acceptability against defined criteria, implement risk control measures, verify effectiveness of controls, assess residual risk and benefit-risk, and monitor through post-production data. Risk-benefit analysis is documented and maintained throughout the product lifecycle.
Key Capabilities
Regulatory Standards Addressed
- ISO 14971:2019 — Application of risk management to medical devices
- EU MDR Annex I — General safety and performance requirements
- FDA QMSR (21 CFR 820, incorporating ISO 13485:2016 §7.3 and §7.1) — Design and risk management
- IEC 62304 — Software risk management
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Want to see this on your own processes?
Bring a real process and we will show it in MoniDoseQMS. Prices start from €49/month (excl. VAT).
Training Management
The right people, with the right training, at the right time
Ensure every team member is qualified for their role. Training records link to your controlled documents. Skills matrices and competency records give you instant visibility into organizational readiness.
How It Works
Define training requirements per role, link training items to controlled documents, assign training when documents are updated, track completion with acknowledgment signatures, manage competency assessments and re-certifications, and generate skills gap reports for management review.
Key Capabilities
Regulatory Standards Addressed
- ISO 13485 Section 6.2 — Human resources / competence
- FDA QMSR (21 CFR 820, incorporating ISO 13485:2016 §6.2) — Personnel competence
- EU MDR Article 10(9) — Personnel competence
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Complaint Handling
Every complaint investigated, every signal detected
Capture product complaints from any source and guide them through investigation, regulatory determination, and resolution. When adverse events require reporting, the platform helps you track vigilance deadlines and keep the reporting records.
How It Works
Receive a complaint, classify it by product, severity, and type, conduct a regulatory reportability determination, investigate with structured root cause analysis, link to CAPA if corrective action is needed, prepare vigilance reports and track regulatory deadlines (you submit to the authority, then record the result here), and review complaint data for signals.
Key Capabilities
Regulatory Standards Addressed
- ISO 13485 Section 8.2.2 — Complaint handling (8.2.1 — Feedback)
- EU MDR Articles 87-92 — Vigilance and post-market surveillance
- FDA 21 CFR 803 — Medical device reporting
- FDA QMSR (21 CFR 820, incorporating ISO 13485:2016 §8.2.2) — Complaint files
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Post-Market Surveillance
Continuous monitoring after your device reaches the market
Systematic collection and analysis of post-market data to confirm ongoing safety and performance. Manage PMS plans, PMCF studies, periodic safety update reports, and trend reports — all connected to your complaint and risk management data.
How It Works
Create a PMS plan defining data sources and review intervals, collect data from complaints, literature, registries, and field safety actions, analyze trends and update risk assessments, generate PSUR or periodic safety update reports, plan and track PMCF studies, and feed findings back into your risk management file.
Key Capabilities
Regulatory Standards Addressed
- EU MDR Articles 83-86 — Post-market surveillance
- EU MDR Article 86 — PSUR
- EU MDR Article 61 — Clinical evaluation / PMCF
- MDCG 2020-7 / 2020-8 — PMCF plan and evaluation report templates
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Electronic Signatures
Part 11-oriented signatures, built into every workflow
Sign records electronically. Every signature captures who signed, when, why and with what meaning, and binds to the SHA-256 hash of the signed file revision. Designed to support 21 CFR Part 11, with open items we track openly.
How It Works
When a record requires approval, the system presents the signature dialog. The signer re-enters their password (accounts are protected by TOTP two-factor login), selects the signature meaning (author, reviewer, approver, etc.), and signs. The signature records the signer, meaning, reason, UTC time and IP address, and is bound to the SHA-256 hash of the signed file revision. Once a record carries any valid e-signature — of any meaning, including a rejection — the record becomes edit-locked: it can no longer be edited in place, and any change must be made by creating a new controlled revision. Regulated records are never physically erased; a deletion soft-archives the record and retains it for the company's defined retention period.
Key Capabilities
Regulatory Standards Addressed
- FDA 21 CFR Part 11 — Electronic Records; Electronic Signatures
- EU MDR Annex II — Technical documentation requirements
- ISO 13485 Section 4.2.5 — Control of records
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Want to see this on your own processes?
Bring a real process and we will show it in MoniDoseQMS. Prices start from €49/month (excl. VAT).
Audit Trail
Who changed what, when, and why — for every record
A tamper-evident, hash-chained record of changes in the system. Inspectors and auditors can trace a change back to the person who made it, when, from which IP address, and what changed.
How It Works
Every create, update, and delete is logged with the user identity, timestamp, IP address, and before and after values. Entries are SHA-256 hash-chained, so any modification breaks the chain, and users cannot edit or delete audit entries. Logs are searchable and exportable for inspections.
Key Capabilities
Regulatory Standards Addressed
- FDA 21 CFR Part 11 — Audit trail requirements
- FDA Data Integrity Guidance — ALCOA+ principles
- ISO 13485 Section 4.2.5 — Control of records
- EU MDR Annex II — Traceability requirements
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Traceability & Design Controls
Connect every requirement to every test to every release
End-to-end traceability from design inputs through verification, validation, and production. When an auditor asks how a requirement was verified, the answer is one click away. Cross-module links show what is affected by a change.
How It Works
Define design inputs (user needs, regulatory requirements), create design outputs (specifications, drawings), link verification activities to specific requirements, document validation results against user needs, manage design changes with impact analysis, keep traceability matrix records, and maintain the design history file throughout the product lifecycle.
Key Capabilities
Regulatory Standards Addressed
- FDA QMSR (21 CFR 820, incorporating ISO 13485:2016 §7.3) — Design controls
- ISO 13485 Section 7.3 — Design and development
- EU MDR Annex II — Technical documentation structure
- IEC 62304 — Software development lifecycle
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Integrations & API Platform
REST API and webhooks for most modules
Connect MoniDoseQMS to the rest of your toolchain. A versioned REST API (add-on, Growth plan and up) covers most modules, scoped per-company API keys keep access controlled, and outbound webhooks push key events to your systems. Bulk import tools handle data onboarding and migration, while a Developer Hub documents the whole surface.
How It Works
Issue a scoped API key from the company settings (keys are hashed at rest, so the full value is shown only once at creation). Call the versioned REST endpoints under /api/v1 to read or write records across modules. Subscribe to outbound webhooks for key events — each delivery is HMAC-signed and recorded in a delivery log you can inspect and retry. Onboard or migrate existing data through the bulk import tools; large imports land as Draft so a qualified user can review and attest before the records become effective.
Key Capabilities
Regulatory Standards Addressed
- FDA 21 CFR Part 11 — Electronic records integrity for API writes
- ISO 13485 Section 4.1.6 — Validation of software used in the QMS
- EU MDR Annex II — Traceability of imported and integrated data
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Expert Network
Outside expertise, inside your QMS
Bring regulatory and quality consultants directly into your quality system. Grant an expert consent-gated, read-only access to the records they need, receive structured recommendations you can act on, and handle hours and invoicing without leaving the platform. Are you a consultant? Join the network.
How It Works
Browse the expert directory and request the expertise you need, or invite a consultant you already work with. You grant consent-gated, read-only access scoped to your company — and you can revoke it at any time. The expert reviews your live records, files structured recommendations against specific modules, and logs hours as they work. Hours flow into built-in invoicing (invoices export as Finvoice 3.0), and expert activity is captured in the audit trail like any other system action.
Key Capabilities
Regulatory Standards Addressed
- ISO 13485 Section 4.1.5 — Control of outsourced processes
- ISO 13485 Section 7.4 — Purchasing and external providers
- ISO 13485 Section 6.2 — Competence of personnel
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
See MoniDoseQMS running on your processes
Bring a real process and we will show it in MoniDoseQMS. Prices start from €49/month (excl. VAT).