ISO 13485 Medical Device QMS Software – Assure, Comply, Excel
Effortless Medical Device Compliance
Bringing medical devices to market or maintaining certification? Zebsoft’s ISO 13485 Medical Device Quality Management Software is your partner in building a connected QMS — so you can prove compliance, reduce risk, and ensure patient safety with confidence.
From Disconnected Files to Integrated Device Quality
Manual spreadsheets and scattered documents aren’t enough in the regulated medical device world. Zebsoft brings everything together into a single system that keeps your QMS organized, your documentation complete, and your teams aligned.
Standards. Build your protection shield.
Bring one or more standards together to build your compliance domain.
Comprehensive ISO 13485 Compliance Made Simple
Zebsoft aligns with every ISO 13485 requirement, providing:
✅ Document & Record Control – Manage procedures, work instructions, and records with version control and approval workflows.
✅ Design & Development Management – Track design history, maintain device master records (DMR), and ensure compliance from concept to market.
✅ Risk Management (ISO 14971 Alignment) – Identify, evaluate, and mitigate risks throughout the product lifecycle.
✅ Supplier Management – Evaluate, approve, and monitor suppliers with full traceability.
✅ Non-Conformance & CAPA – Capture, investigate, and resolve issues with clear accountability.
Features That Prove Your Commitment to Quality and Compliance
✅ Centralized document libraries for procedures, forms, and records
✅ Linked design files and risk assessments
✅ Automated workflows for approvals, reviews, and updates
✅ Supplier approval tracking with audit trails
✅ Auditor-ready reports demonstrating QMS effectiveness
Master ISO 13485 Quality Actions with Zebsoft
Zebsoft turns regulatory complexity into a streamlined, connected QMS:
✅ Connect Design Controls to Device Records
Link every design activity directly to your device master and technical files.
✅ Plan and Assign Internal Audits with Confidence
Schedule ISO 13485-compliant audits, track findings, and follow up with corrective actions.
✅ Empower Teams to Raise Issues and Suggestions
Give every employee a voice in improving processes, product quality, and patient safety.
✅ Prove Compliance with Data-Driven Reports
Generate auditor-ready reports for regulatory bodies and notified bodies.
✅ Trigger CAPA Instantly from Any Finding
Launch corrective or preventive actions directly from audits, complaints, or non-conformities.
Build a Culture of Quality, Not Just Compliance
Zebsoft helps embed ISO 13485 responsibilities throughout your organisation:
✅ Empower Staff with Clear, Easy-to-Use Tools
Make reporting issues or accessing controlled documents simple for everyone.
✅ Enable Managers to Drive Device Quality Improvements
Assign, track, and escalate tasks with full accountability.
✅ Give Executives Complete Oversight of QMS Performance
Provide dashboards showing key performance indicators, trends, and compliance status.
✅ Maintain Evidence-Backed, Role-Based Traceability
Every record, approval, and change is linked to user permissions for total regulatory compliance.
From managing design controls to proving QMS effectiveness to regulators — Zebsoft unites it all in one integrated ISO 13485 quality management platform.
Why Choose Zebsoft for ISO 13485?
✅ Fully Integrated QMS – Manage ISO 13485 requirements alongside ISO 9001, 14971, and other standards.
✅ Automated Traceability – Every record and approval is tracked, creating complete design and compliance history.
✅ Dynamic Dashboards – Get live insights into QMS status and device development progress.
✅ Role-Based Access – Control who can view or edit documents, ensuring security and compliance.
Achieve and Maintain ISO 13485 Certification with Confidence
Preparing for ISO 13485 certification, managing audits, or updating your QMS for regulatory changes? Zebsoft helps you achieve and maintain certification with ease.
Through our network of accredited auditors and experienced medical device consultants, certification support can be included with your implementation plan.
Whether you’re:
✅ Seeking your first ISO 13485 certification,
✅ Managing surveillance or recertification audits, or
✅ Updating your QMS to align with new MDR/IVDR requirements,
Zebsoft keeps you audit-ready and fully compliant.
💡 Want certification support included? Ask us today and simplify your path to ISO 13485 success.
Learn More About ISO 13485
For official details on the ISO/IEC 27001 standard, visit the ISO 13485 information page.
