ISO 13485 Consulting and QMS Implementation Support

ReadySet enables MedTech companies to deploy a structured ISO 13485 Quality Management System independently and adapt it to their activities, products, and regulatory scope.

When additional guidance is needed, AZ Biotech Consulting provides optional ISO 13485 consulting to support QMS implementation, documentation structuring, certification preparation, and regulatory compliance.

Support for ReadySet Implementation

ReadySet is designed to be implemented independently by your team.

However, some organizations prefer additional guidance when adapting the system to their specific activities, products, or regulatory scope.

For this reason, ReadySet users benefit from optional expert support provided by AZ Biotech Consulting.

Typical support topics

• understanding the QMS architecture
• adapting procedures to your organization
• structuring your documentation
• preparing your team to operate the QMS
• implementing workflows and document control

Regulatory guidance

Beyond the implementation of the quality system, organizations may require guidance on their regulatory strategy.

AZ Biotech Consulting provides support for:

• ISO 13485 certification preparation
• MDR and IVDR regulatory strategy
• structuring technical documentation
• risk management implementation
• preparation for regulatory audits

This guidance helps align your quality system with your regulatory strategy and market access objectives.

Technical documentation

ReadySet includes a structured framework for managing technical documentation.

AZ Biotech Consulting can support organizations in structuring their product documentation, including:

• Design History File (DHF)
• Device Master Record (DMR)
• Technical File or Technical Documentation

This support aims to establish documentation that is consistent, complete, and aligned with applicable regulatory expectations.

Flexible support adapted to your needs

Support can be provided in a flexible way depending on your organization’s needs.

Typical formats include:

• short advisory sessions
• targeted support for specific topics
• guidance during key project phases
• preparation for certification audits

The objective is to provide practical and efficient support while keeping your team autonomous.

Need support?

If you would like guidance in deploying ReadySet or structuring your Quality Management System, feel free to contact us.