ISO 13485 QMS – The Fastest Way to Deploy Your Quality System

ReadySet is a ready-to-use ISO 13485 QMS designed for MedTech companies. Built on Atlassian Confluence, it helps you deploy a structured quality management system quickly and efficiently.

Building a compliant Quality Management System from scratch can take months.
ReadySet provides a structured framework that allows you to start operating your QMS immediately and adapt it to your product and organization.

Watch a short introduction to understand how ReadySet helps MedTech teams deploy a structured QMS quickly.

Why Implementing an ISO 13485 QMS Is Challenging

For many MedTech startups and growing companies, implementing a Quality Management System is one of the most complex steps in the regulatory journey.

Teams often struggle with:

• understanding regulatory requirements
• structuring documentation
• implementing consistent processes
• preparing for certification audits

Without a clear structure, the process can take 6 to 12 months and require significant consulting support.

Accelerate ISO 13485 Compliance with a Ready-to-Use QMS

ReadySet provides a complete and structured Quality Management System delivered as a ready-to-deploy Confluence workspace.

It includes the key processes and documentation structure required for an ISO 13485 compliant QMS.

This allows teams to focus on their product development while implementing a professional and scalable regulatory framework.

ReadySet includes:

• ISO 13485-aligned QMS processes
• ready-to-use procedures and templates
• structured documentation framework
• CAPA and risk management tools
• traceable document lifecycle

One ISO 13485 QMS Adapted to Your Medical Device

ReadySet provides a flexible QMS framework that can be adapted to different types of medical technologies.

Whether you develop:

• medical devices
• in vitro diagnostics
• software as a medical device

you can start with the same structured system.

Simply keep the elements relevant to your product and remove what is not applicable.

This approach allows companies to deploy a professional QMS quickly while maintaining flexibility.

What Is Included in This ISO 13485 QMS

ReadySet contains the essential building blocks of a modern Quality Management System.

The framework includes processes and templates for:

• Quality management and governance
• Risk management (ISO 14971)
• Design and development control
• Supplier management
• CAPA and continuous improvement
• Document control
• Technical documentation structure
• Post-market activities

The system is designed to provide traceability, clarity and audit readiness.

ISO 13485 QMS Built on Atlassian Confluence

This ISO 13485 QMS is fully implemented in Atlassian Confluence, providing a collaborative environment to manage documentation, workflows and traceability.

ReadySet is delivered as a Confluence workspace that can be imported and deployed immediately.

This approach provides a collaborative and transparent environment for managing your Quality Management System.

ReadySet integrates naturally with tools such as:

• Confluence macros
• Jira for traceability
• electronic approval workflows
• document lifecycle management

This allows your quality system to evolve naturally with your development processes.

Expert support when you need it

ReadySet can be implemented independently by your team.

However, when additional guidance is required, AZ Biotech Consulting provides expert support to help you adapt the system to your organization.

Support may include:

• QMS customization
• regulatory strategy
• audit preparation
• technical documentation structuring

Our objective is to help you deploy a robust and efficient quality system with minimal complexity.

Start your QMS with ReadySet

Accelerate your regulatory journey and deploy a structured Quality Management System in days instead of months.