Connected medical devices can be used to track lifestyle diseases such as hypertension, diabetes, and asthma, which need continuous monitoring. Companies like Vocera® are leading the way by providing smart communication devices for healthcare workers and those on the front lines.4
Medical device manufacturing innovators deal with a myriad of obstacles to commercialize and sell products in the U.S. and other countries around the world. The need to manage the design, development, quality, and approval processes is critical to gain FDA approval or comply with ISO regulations like 13485. Arena helps medical device companies move from early research and development to product launch with cloudbased quality management system (QMS) solutions built for today’s sophisticated device designs and distributed teams.
Arena QMS helps medical device manufacturers speed product development with a single system for the product record and associated quality and compliance records. Taking a product-centric approach, Arena helps companies manage quality processes in context to the full product record, which includes assemblies or bills of materials (BOMs), design history files (DHFs), and device master records (DMRs). As companies increase the number of sensors, electronics, and software used in their IoT devices, Arena makes it easy to keep all design, development, quality, and compliance information in a single controlled system that provides maximum traceability throughout the product development process.
