SmartEye replaces scattered Word files, spreadsheets and wet signatures with one secure, connected system. Manage documents, design history, risk, change control, CAPA and training in one place — and walk into every audit with full traceability from user need to release.
Built by medical device QARA and software engineers who have lived through notified-body audits. SmartEye turns the quality system from a filing exercise into a daily tool your engineers, QA and regulatory teams actually use.
Every document, decision and signature is traceable, time-stamped and one click away when the auditor asks.
Complaints, non-conformances, CAPAs and design changes link to each other, so no issue is lost between teams.
Pre-built ISO 13485, ISO 14971 and IEC 62304 structures mean you build your QMS in weeks, not months.
Integrated Management System
One document control system for ISO 13485, ISO 9001, ISO/IEC 27001, ISO 45001, ISO 14001 and more.
TRACEABILITY ENGINE
See every missing link — untested requirements, uncontrolled risks, unsigned records — before your auditor does.
24 user needs, 68 software requirements, 38 ISO 14971 hazards and 142 test protocols — every one linked, with no orphans.
"Device shall alert the clinician immediately if patient heart rate exceeds 140 BPM."
| User need | Software requirement (IEC 62304) | Hazard & control (ISO 14971) | Verification | Release evidence | Status |
|---|---|---|---|---|---|
|
UN-102
Alert clinician if heart rate exceeds 140 BPM. |
SRS-402
Tachycardia detection triggers audible and visual alarm within 1.5 s. |
HAZ-089
Delayed alert. Control: redundant polling loop. |
TC-812 passed | EVD-2026-089 Approved · Part 11 signed | ✓ Trace complete |
|
UN-105
Patient data stays protected in transit and at rest. |
SRS-518
Telemetry encrypted with AES-256 and rotated keys. |
HAZ-104
Data interception. Control: TLS 1.3 mutual auth. |
TC-945 passed | EVD-2026-104 Approved · Part 11 signed | ✓ Trace complete |
|
UN-114
Monitoring continues during a power fluctuation. |
SRS-607
Switch to backup battery within 12 ms without reboot. |
HAZ-132
Sudden reset. Control: supercapacitor bridge. |
TC-1042 passed | EVD-2026-132 Approved · Part 11 signed | ✓ Trace complete |
Enterprise Capabilities
Unify clinical, engineering, quality and regulatory teams in one compliant system.
Run design control the way your engineers already work, without slowing sprints down.
A living risk file that updates as the design changes.
Every test traced to the requirement it proves.
Controlled documents with a full, tamper-evident history.
Your design history and technical file, structured for submission.
Close the loop from field feedback to a verified fix.
Your quality data, protected by design.
Clinical evidence linked to the design it supports.
Roles & Permissions
Within each role, give people Author, Reviewer, Approver or Read-only rights per folder, so the right person signs the right document.
Sets up the company, users, departments and access across every project.
Runs one project: its team, folders, risk matrix and approvals.
Oversees CAPAs, complaints, NCs and audits across every department, and owns the QMS configuration.
Authors, reviews, approves and trains on the work assigned to them.
Time-limited, read-only access for auditors, suppliers and consultants.
Device Classification Solutions
Select your device classification to view regulatory deliverables, documentation structure and typical timelines.
AI/ML diagnostics · digital therapeutics · remote patient monitoring
Infusion pumps, surgical instruments, monitoring consoles
Hardware/software matrix synchronization, hazard mitigation traceability.
Get Class IIa / IIb Medical Devices Template Pack →Cardiac pacemakers, neurostimulators, critical life-support
Full bi-directional trace rigor from clinical evaluation to post-market surveillance.
Get Class III & Implantables Template Pack →Molecular testing assays, point-of-care analyzers, automated reagents
Performance evaluation reports, analytical validation protocols, lot traceability.
Get In Vitro Diagnostics (IVD) Template Pack →The SmartEye Advantage
Legacy binders and generic tools, compared with an eQMS built for medical devices.
Regulatory Frameworks
Built around international harmonised standards for medical devices and the regulations of the markets you sell into.
QMS library organised clause by clause, from 4.1 to 8.5.
Risk management plan, FMEA and risk-benefit, linked to design.
Software lifecycle, safety class and SOUP records for SaMD.
E-signatures, audit trails and access controls built in.
Aligned with the FDA QMSR in force since 2 Feb 2026.
Technical documentation structured to Annex II and III.
Usability engineering file linked to risks and validation.
Personal data handled under UK and EU GDPR.
S-Cube Technologies is BSI-certified to ISO 9001.
S-Cube Technologies is BSI-certified to ISO/IEC 27001.
Connected Toolchain
No double data entry. Your engineers keep their tools; your quality records stay controlled.
Author in Word, review and sign in SmartEye.
Link epics and stories to design inputs and tests.
Trace work items to requirements and verification.
Need another tool? Ask us about our open API.
FAQ
Everything you need to know about SmartEye. Can't find your answer? Talk to our team.
SmartEye runs on Microsoft Azure, with encryption in transit and at rest, role-based access and daily backups. S-Cube Technologies is BSI-certified to ISO/IEC 27001.
It gives you a QMS already structured around ISO 13485, ISO 14971, FDA 21 CFR Part 820 and EU MDR, with controlled documents, e-signatures and audit trails. Your team fills in your processes instead of building the system from scratch.
Yes. Design control, risk management and verification follow IEC 62304 and IEC 62366-1, with traceability from user needs to release.
SmartEye works with Microsoft Office, Jira and Azure Boards, so engineers keep their tools while quality records stay controlled.
Yes — for the QMS (ISO 13485), risk (ISO 14971), software (IEC 62304), usability (IEC 62366-1), EU MDR technical documentation and FDA design control. Adapt them to your processes.
Authors, reviewers and approvers work on the same record with comments, tasks, due dates and notifications. Everyone sees what is waiting for them on their dashboard.
Yes. We migrate documents, records and suppliers from paper, SharePoint or another eQMS, and keep their legacy IDs.
SmartEye supports UK, EU, US and other regulatory frameworks, and customers use it on five continents.
SmartEye is cloud-based (SaaS), with monthly or annual subscriptions. There is nothing to install.
Most teams are live in 2–4 weeks, including configuration, data migration and training.
Yes. Each customer can be paired with a dedicated QA/RA specialist for audits, submissions and QMS set-up.
No. Upgrades are included, and we provide IQ/OQ/PQ validation reports for each release at no extra charge.
Schedule a Consultation
See SmartEye with your own device and standards in a 45-minute demo — no slides, no obligation.