Streamline Your Compliance with AZ Biotech Consulting

At AZ Biotech Consulting, we provide a comprehensive suite of solutions and services designed to simplify your regulatory processes, accelerate certification, and enhance your product’s market readiness.

QMS_ReadySet for Confluence

The QMS_ReadySet is a pre-configured Quality Management System (QMS) built on Confluence, offering a complete and practical framework to help you achieve compliance faster and more efficiently.

It is available in three specialized versions, each tailored to the specific regulatory requirements of your product category:

• QMS_ReadySet MDR – for Medical Devices in compliance with EU MDR and ISO 13485.
• QMS_ReadySet SW – for Medical Device Software (SaMD), aligned with IEC 62304, ISO 14971, and relevant software lifecycle standards.
• QMS_ReadySet IVDR – for In Vitro Diagnostic Devices (IVD), covering EU IVDR, ISO 13485, and performance evaluation requirements.

Each QMS_ReadySet package includes:

• Ready-to-use procedures, templates, and forms aligned with ISO 13485 and applicable regulations.
• A dedicated space for managing technical documentation, including the Design History File (DHF), Device Master Record (DMR), and Technical File (TF).
• A clear structure that supports traceability, document control, and lifecycle management for all product types.

Whether you develop hardware, diagnostic kits, or software, the QMS_ReadySet provides a scalable, compliant foundation for your quality and regulatory system — accelerating your route to certification and market approval.

In addition, the ReadySet features a dedicated space for managing technical documentation, including the Design History File (DHF), Device Master Record (DMR), and Technical File (TF). This structure supports regulatory compliance across the entire product lifecycle and is tailored to the documentation needs of Medical Devices (MD), In Vitro Diagnostic Devices (IVD), and Software as a Medical Device (SaMD) in accordance with ISO 13485, 21 CFR 820, EU MDR, EU IVDR, and IEC 62304.

Expert Support and Tailored Consulting

AZ Biotech consulting offers personalized support to adapt your QMS and technical documentation to your company’s specific activities, structure, and product portfolio.
From initial setup to certification and post-market follow-up, we ensure your quality system is not only compliant, but also efficient, scalable, and aligned with your innovation strategy.