Expert guidance to help you make the most of QMS_ReadySet
At AZ Biotech Consulting, we believe that regulatory compliance should be clear, structured, and efficient.
That’s why we combine our QMS_ReadySet solutions with dedicated support and consulting services, ensuring that every organization — from start-up to established manufacturer — can deploy its quality system smoothly and effectively.
🧭 Support
For all users of QMS_ReadySet (MDR, SW, or IVDR), we offer one hour of free consultancy to help you get started and make the most of your new system.
This session can cover topics such as:
- Getting familiar with your Confluence setup;
- Adapting document templates and procedures;
- Understanding ISO 13485 structure and workflow management.
Our goal is to ensure a seamless onboarding experience so you can focus on your product development and certification journey.
⚙️ Consulting
Every company is unique — and so are its products and processes.
If desired, AZ Biotech Consulting can assist you in customizing your QMS_ReadySet to reflect your organization’s specific structure, product portfolio, and regulatory scope.
We provide hands-on guidance to:
- Align procedures with your internal workflow;
- Integrate risk and CAPA management tools;
- Streamline documentation for MDR, IVDR, or IEC 62304 compliance.
Beyond QMS_ReadySet, we also offer specialized consulting in:
- Regulatory compliance (MDR, IVDR, ISO 13485);
- Quality Management System implementation and certification;
- Strategic and regulatory planning for MedTech start-ups;
- Software development compliance for medical devices (SaMD).
💶 Pricing
Our consulting rate is €90/hour.
Belgian clients can benefit from the “Chèques-Entreprises” program, for which AZ Biotech Consulting is an accredited service provider.