Built for compliance. Designed for people.
Every capability is designed around one goal: making quality management faster, simpler, and audit-ready from day one. Each module maps to specific regulatory requirements so you always know what is covered.
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. Automated workflows ensure every SOP, work instruction, and form goes through proper review and approval before release. No more chasing signatures or wondering which version is current.
How It Works
Draft a document, assign reviewers and approvers, collect electronic signatures with meaning codes, release the approved version to controlled distribution, and track read receipts. When a periodic review is due, the system notifies the document owner automatically. Previous versions are archived with full audit trail.
Key Capabilities
Regulatory Standards Addressed
- ISO 13485 Section 4.2.4 — Control of documents
- FDA 21 CFR 820.40 — Document controls
- 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 using built-in 5-Why or fishbone tools, 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 21 CFR 820.90 — Nonconforming product
- FDA 21 CFR 820.100 — Corrective and preventive action
- 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 8.2.2 — Internal audit
- FDA 21 CFR 820.22 — Quality 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 21 CFR 820.30(g) — Design validation including risk analysis
- IEC 62304 — Software risk management
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Training Management
The right people, with the right training, at the right time
Ensure every team member is qualified for their role. When a document changes, affected training assignments are triggered automatically. 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, automatically 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 21 CFR 820.25 — Personnel
- 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 meet vigilance obligations on time.
How It Works
Receive a complaint, automatically 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, submit vigilance reports within regulatory timelines, and track trending data across all complaints for signal detection.
Key Capabilities
Regulatory Standards Addressed
- ISO 13485 Section 8.2.2 — Feedback / complaints
- EU MDR Articles 87-92 — Vigilance and post-market surveillance
- FDA 21 CFR 803 — Medical device reporting
- FDA 21 CFR 820.198 — 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 85 — PSUR
- EU MDR Article 61 — Clinical evaluation / PMCF
- MEDDEV 2.12/2 rev 2 — PMS guidelines
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Electronic Signatures
Regulatory-grade signatures, built into every workflow
Sign records electronically with full regulatory acceptance. Every signature captures who signed, when, and the meaning of that signature. Tamper-evident records satisfy the strictest regulatory requirements for data integrity.
How It Works
When a record requires approval, the system presents the signature dialog. The signer authenticates (username + password, or MFA if configured), selects the signature meaning (author, reviewer, approver, etc.), and signs. The signature is cryptographically linked to the record content. Any subsequent change to the record invalidates the signature and requires re-signing.
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
- EU eIDAS Regulation — Electronic identification
Connected Modules
All modules share a common audit trail and can cross-reference records for full traceability.
Audit Trail
Who changed what, when, and why — for every record
A complete, immutable record of every action taken in the system. Inspectors and auditors can trace any change back to the person who made it, when they made it, and the reason behind it. No gaps, no questions.
How It Works
Every create, read, update, and delete operation is automatically logged with the user identity, timestamp, IP address, old value, new value, and reason for change (when applicable). Audit trail records cannot be modified or deleted by any user, including administrators. Logs are searchable, filterable, and exportable for regulatory 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. Impact analysis shows exactly what is affected by any 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, generate traceability matrices automatically, and maintain the design history file throughout the product lifecycle.
Key Capabilities
Regulatory Standards Addressed
- FDA 21 CFR 820.30 — 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.