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The burden to get compliant medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved—so, too, has the weight of the burdens these leaders face.
We help you overcome these challenges to eliminate product launch process delays, reduce compliance risks, and remove barriers that impede innovation.
Arena Quality Management System (QMS) software connects closed-loop quality management with product development processes in a single system. This product-centric approach simplifies compliance and reduces internal or external (FDA or ISO) audit risks.
Our closed-loop quality management system provides quality teams with better transparency and traceability throughout the entire new product development and introduction process. This includes supporting compliant design controls. With Arena QMS, you can focus on what you do best using Arena’s validation maintenance service (VMS). This makes it easier for you to meet FDA software validation regulations.
Arena QMS enables your teams to manage quality (DMRs, DHFs, SOPs, CAPAs) and training records in context to the entire product record (items, BOMs, AML/AVL). We streamline closed-loop quality management processes to reduce compliance and audit risks while enabling continuous improvement.
Track employee and partner training on new and revised standards, instructions, and procedures. Arena Training manages your employee and partner training plans and ensures everyone can demonstrate competency.
Synchronize inspection tests with the product revision. Arena integrates with quality control, CRM, and manufacturing execution systems. Quality assurance teams can define, revise, and review test specifications fast.
Medical device manufacturers face many challenges—including 510(k) submissions and premarket approvals (PMA)—in their product launch journey before they can sell devices commercially. Arena QMS accelerates the development and delivery of safe products.
Arena Solutions helps your quality teams:
quality and product processes for better control and traceability
and resolve issues with closed-loop corrective and preventive actions (CAPA)
compliance with FDA 21 CFR Part 820, Part 11, and ISO 13485
to current good manufacturing practices (cGMPs)
with FDA software validation requirement and reduce risks
See why Arena’s product-centric QMS is better.
