As you start to revisit your current quality processes and compile all the necessary product data for IVDR compliance, you may find it overwhelming to manage, especially if you are working with manual, paper-based, or siloed systems.
Using an enterprise quality management system (eQMS) like Arena’s cloud-based QMS reduces the burden of meeting compliance by linking all of your product information and quality processes in one shared platform. Unlike traditional document-based systems, which 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), approved manufacturer/vendor lists (AMLs/AVLs), technical documentation, product history, and any changes or quality issues. This product-centric approach to QMS enables greater visibility, traceability, and control throughout the entire product lifecycle and reduces compliance risks.
With access to a single, unified system, dispersed product teams and supply chain partners can easily collaborate anytime and anywhere. This eliminates silos and enables impacted teams to quickly identify, analyze, and resolve quality issues. And because all the performance evaluation reports, post-market surveillance reports, and other technical documentation necessary for IVDR compliance are connected and easily extractable—you can be confident that product data is always accurate and audit-ready. Ultimately, with Arena QMS your team can spend less time managing documents and focus on delivering innovative, safe, and effective products that improve the quality of patients’ lives.