ISO 13485 Medical Device Compliance with Zebsoft
Total Control for Medical Device Quality Systems
ISO 13485 isn’t just ISO 9001 with a new badge — it’s a high-stakes quality framework that demands traceability, control, and evidence at every step. Zebsoft provides a structured system to meet regulatory requirements, support certification, and improve lifecycle oversight.
From design inputs to device history, Zebsoft helps you build a QMS you can trust.
What ISO 13485 Requires — All in One System
Most ISO management systems follow the same structure — and Zebsoft is engineered to reflect that by controlling all standards with the same functionality.
| Requirement Area | Zebsoft Feature / Module |
|---|---|
| Quality Manual & Document Control | Fully Controlled Document Register |
| Management Responsibility | Role Assignment + Review Templates |
| Training, Competence & Awareness | People Module + Skill Tracking |
| Product Lifecycle Records | Asset Register + Product Tagging |
| Risk Management | Risk Register with Custom Medical Flags |
| Design & Development | Controlled Document Embedding + References |
| Purchasing & Supplier Control | Supplier Portal + Evaluation Logs |
| Product Identification & Traceability | Serial No. Linked Records |
| Process Validation | Procedure Mapping + Control Verification |
| Control of Monitoring & Measuring Devices | Calibration Logs + Asset History |
| Nonconformity & CAPA | Linked Tasks, Incidents, and Change Control |
| Internal Audits | Scheduler + Checklist Engine |
Designed for Regulatory and Clinical Confidence
Zebsoft ensures ISO 13485 isn’t just “file and forget.”
It delivers real-time oversight of your medical device processes:
📄 Control all documents with authorisation and version history
🔍 Track product records from initial design to end-of-life
🧪 Link verification steps directly to risks and procedures
📈 Capture and resolve nonconformities with full CAPA linkage
🗂️ Manage supplier approvals and regulatory documentation in one place
One System, Full Lifecycle
Whether you’re building, validating, or post-market servicing, Zebsoft helps manage your medical QMS across all phases:
- Connect design documents to test and validation records
- Allocate team roles and training based on device class or site
- Maintain device traceability records by serial number
- Manage calibration, servicing, and field feedback in one register
No duplication. No spreadsheet confusion. One audit-ready platform.
hare Features with 9001, Extend Where Needed
Zebsoft allows you to build ISO 13485 on the same foundation as ISO 9001 — but extend it with medical device-specific layers:
- Document Control
- Training & Roles
- Internal Audit
- Risk Management
- CAPA
- Supplier Control
- Management Review
Then add:
- Lifecycle traceability
- Product and calibration logs
- Custom field validation
- Clinical review references
For Manufacturers, Auditors, and Operators
- Device engineers manage procedures and traceability
- Quality teams conduct audits and CAPA follow-up
- Management review data flows from real-time reports
- Everyone sees only what they need, when they need it
Everything permissioned. Everything traceable.
Why Zebsoft for ISO 13485?
✅ Built on ISO QMS principles
✅ Designed for medical device regulatory pathways
✅ Fully controlled documents and procedures
✅ Traceability from design through lifecycle
✅ Integrated audit, CAPA, and supplier controls
✅ Multi-role system visibility and control
Start with the Foundation Shield — Then Add Depth
Zebsoft’s Foundation Shield gives you everything you need to start managing ISO 13485, including:
- Document Control
- Internal Audit
- Roles & Training
- Risk Register
- Supplier Management
- Continuous Improvement
- CAPA
When ready, add traceability, validation, or lifecycle features as your process matures.
Optional Certification Support
Looking to achieve or maintain ISO 13485 certification?
Zebsoft doesn’t just support your compliance — we can help you get certified too.
Through our trusted network of accredited auditors and consultants, certification services can be included as part of your implementation plan.
Whether you’re preparing for first-time certification, managing a surveillance audit, or transitioning to a new version of the standard, we’ve got you covered.
💡 Ask us about adding certification support to your package.
Not Sure Where to Start?
Find Your Fit:
Zebsoft adapts to you. Whether you’re responsible for compliance, operations, security, or strategy, this guided form will help pinpoint the ideal system configuration for your role and needs.
Step in. Answer a few simple questions.
We’ll show you exactly how Zebsoft fits — from modules to Shields, with a clear outcome.
No jargon. No overwhelm. Just clarity.
Let’s build the right solution together.
