Zebsoft Medical Device Quality Management Software simplifies compliance with ISO 13485, enabling complete control of documents, processes, risks, and design history records.
Built for manufacturers, assemblers, and service providers in the medical device sector, Zebsoft connects every stage — from concept and design through production and post-market surveillance.

With linked risk registers, automated approvals, and full audit traceability, you can demonstrate conformity to ISO 13485, MDR, and FDA 21 CFR 820 requirements — while maintaining efficient, evidence-based operations.

Zebsoft transforms ISO 13485 compliance from a document-heavy burden into a dynamic, auditable management system.
Every process — from device design to complaint handling — becomes traceable, monitored, and continuously improved.

Zebsoft aligns with ISO 13485 clauses and regulatory requirements, providing:

✅ Design & Development Controls – Manage design inputs, outputs, reviews, and verification in one system.
✅ Risk Management Integration – Link ISO 14971 risk assessments directly to design and process records.
✅ Document & Change Control – Version control with approval workflows and audit history.
✅ Supplier & Purchasing Oversight – Evaluate, approve, and monitor critical suppliers.
✅ Training & Competency Records – Maintain evidence of qualified personnel for regulated processes.
✅ Corrective and Preventive Actions (CAPA) – Record nonconformities, root causes, and improvements.
✅ Audit Scheduling & Tracking – Plan and evidence internal and external audits.
✅ Device Master Record & DHF Management – Maintain product history and traceability.

✅ Centralised design, production, and quality documentation
✅ Linked risk and CAPA controls across all quality processes
✅ Task assignment with clear ownership and accountability
✅ Auditor-ready reports demonstrating compliance and improvement
✅ Dashboards tracking quality objectives, KPIs, and audit findings
✅ Integrated training and competency management for regulated roles
✅ Automated notifications for review, calibration, and validation dates
✅ Cross-standard alignment with ISO 9001, ISO 14971, and MDR requirements
✅ Role-based oversight for QA, engineering, and management teams
✅ Real-time evidence of continual improvement for UKAS and notified-body audits

Zebsoft turns medical device quality management into an active, data-driven discipline:

✅ Connect Risks to Design & Process Controls – Ensure every hazard is identified, mitigated, and recorded.
✅ Automate Document Approvals – Eliminate manual signatures with traceable digital workflows.
✅ Enable Teams to Report Nonconformities – Capture deviations instantly from any site or production cell.
✅ Prove Compliance Through Evidence – Generate instant audit trails and certification-ready reports.
✅ Launch CAPA Actions Instantly – Contain issues, assign actions, and verify effectiveness with built-in review cycles.

Quality and safety aren’t separate tasks — they’re shared responsibilities. Zebsoft embeds ISO 13485 principles into everyday operations by linking training, competency, and accountability across your organisation.
Executives gain live visibility into product status; engineers maintain version-controlled records; auditors access verified evidence — all from one secure environment.

✅ End-to-end traceability from design to distribution
✅ Built-in compliance with ISO 14971 and MDR requirements
✅ Automated document and change control workflows
✅ Live dashboards showing audit readiness and product performance
✅ Integration with supplier, risk, and training modules
✅ Evidence-based verification for regulatory and notified-body audits

Zebsoft helps medical device companies achieve and maintain ISO 13485 certification efficiently.
Through our network of experienced auditors and quality specialists, certification support can be added to your implementation plan.

Whether you’re preparing for your first certification, managing a surveillance audit, or aligning with MDR and FDA expectations, Zebsoft provides the governance structure to prove compliance and protect patients.

💡 Want certification support included? Ask us today and simplify your path to ISO 13485 success.

For official details on ISO 13485 Quality Management Systems, visit the ISO 13485 information page.