Accelerate Your Path to Compliance With Arena QMS

Updating your QMS and compiling evidence for TGA’s conformity assessment may seem daunting, especially if you are working with paper-based or siloed systems.

Using a proven cloud-native QMS solution like Arena reduces the compliance burden by linking all your product information and quality processes in one shared platform. While traditional document-based systems fail to manage the complete product record, Arena QMS manages linked relationships between device master records (DMRs), design history files (DHFs), bills of materials (BOMs), supplier information, technical documentation, and any changes or quality issues. This product-centric approach drives greater visibility, traceability, and control throughout the entire product lifecycle and reduces compliance risks.

By leveraging Arena’s quality templates, you can quickly build post-market surveillance reports, corrective action reports, and other critical records. Plus, everything is connected and easily extractable, ensuring that product information is always audit ready.

Our team of QMS experts are here to guide you through the process and set you up for success. Contact us today to get started!

References

1. Australian Regulatory Guidelines for Medical Devices
2. Quality, Safety, and Performance Requirements for Medical Devices (the Essential Principles)
3. Demonstrating Evidence to Comply With the Essential Principles
4. What Classification Is My Medical Device?
5. Classifying In Vitro Diagnostic Medical Devices (IVDs) for Supply in Australia