Your Ready-to-Use ISO 13485 Quality Management System
QMS_ReadySet is a complete, audit-ready documentation solution designed for manufacturers of Medical Devices (MD), In Vitro Diagnostic Devices (IVD), and Medical Device Software (SaMD) who want to achieve fast and efficient compliance with ISO 13485, EU MDR, and EU IVDR requirements.
Built on Confluence, QMS_ReadySet provides a fully structured, digital Quality Management System (QMS) — ready to deploy, customizable, and scalable to your company’s size and activity.
🚀 Accelerate Your Compliance
QMS_ReadySet simplifies the implementation of your Quality Management System through:
- A predefined ISO 13485 structure with 12 core quality processes.
- Standardized templates for procedures, forms, and references (SOP, PROC, FOR, REF).
- Electronic signature and approval workflow for controlled validation.
- Secure access and version control within Confluence.
- A customizable framework to reflect your company’s structure, products, and regulatory scope.
🧱 Three Specialized Versions
To best support your product category, QMS_ReadySet is available in three dedicated versions:
QMS_ReadySet MDR
For Medical Device manufacturers complying with EU MDR (2017/745) and ISO 13485:2016.
Includes processes and templates tailored for device design, manufacturing, post-market surveillance, and regulatory reporting.
QMS_ReadySet IVDR
For In Vitro Diagnostic (IVD) manufacturers aligning with EU IVDR (2017/746).
Integrates documentation for performance evaluation, verification, and risk management specific to IVD development.
QMS_ReadySet SW
For Software as a Medical Device (SaMD) and embedded software developers.
Covers IEC 62304 (software lifecycle), ISO 14971 (risk management), and software validation documentation requirements.
⚙️ What’s Inside
Core QMS Processes (ISO 13485-aligned)
- QMS – Quality Management
- RIS – Risk Management
- DND – Design & Development
- MNO – Manufacturing & Operations
- SUP – Supply Chain
- HUM – Human Resources
- INF – Infrastructure
- DOC – Documentation
- MAN – Management
- CON – Control
- IMP – Continuous Improvement
- SAL – Sales
Document Types
- SOP – Standard Operating Procedures
- FOR – Forms for recording data
- REF – Internal and regulatory references
All documents follow a controlled lifecycle (Draft → Review → e-Signature Approval → Publication → Archiving), ensuring traceability and audit readiness.
🛡️ CAPA and Risk Management
QMS_ReadySet integrates CAPA and risk analysis tools directly within Confluence:
- CAPA space with standardized forms and full traceability.
- Risk management using FMEA methods for processes and products.
- Pre- and post-mitigation assessments linked to procedures and controls.
This ensures a homogeneous and traceable risk management system across your QMS.
🔗 Seamless Confluence Integration
Delivered as a Confluence space backup, QMS_ReadySet can be imported instantly and works with your existing setup.
Compatible with:
- Confluence macros (Table Filter, Charts & Spreadsheets)
- Jira integration for ticket tracking and traceability
- Electronic signature plugins (Comala, eSign, Page Approval)
💼 Who It’s For
- Start-ups preparing for ISO 13485 or CE certification.
- SMEs structuring or scaling their QMS.
- Manufacturers expanding into MDR, IVDR, or SaMD.
- Consultants seeking a ready-to-use, compliant framework.
💶 Pricing (Perpetual License)
| Company Size | Price (excl. tax) |
|---|---|
| < 15 employees | €2,600 |
| < 150 employees | €3,900 |
| Unlimited | €5,300 |
(Confluence, macros, and e-signature licenses not included.)