Empowering Innovation in Medical Device Development
In the realm of medical device development, engineering teams face numerous challenges in ensuring timely and efficient product design. The convergence of electrical, mechanical, and software design components necessitates a cohesive approach to guarantee interoperability throughout the development process. Arena Solutions PLM offers a comprehensive Quality Management System (QMS) software solution that centralizes the entire product record and links it to pertinent quality records. By adopting a product-centric QMS strategy, all essential elements such as items, bills of materials (BOMs), approved manufacturers (AML), and related documents are meticulously controlled within a unified platform.
Enhancing Cloud QMS for Design and Quality Control
The transition from initial concept to sustaining existing products is streamlined with Arena's cloud-based, Quality Management System. The software encompasses requirements management, issue management, and project management utilities that seamlessly integrate with Arena QMS, facilitating the expeditious design and development of safe devices. Designing products with manufacturability in mind is further simplified as Arena offers real-time access to vital product information, ensuring alignment between design and manufacturing capabilities.
Facilitating Multidisciplinary Collaboration
Arena Solutions bolsters multidisciplinary collaboration by reducing engineering change order (ECO) review cycles through automated routing and approval processes. This functionality empowers engineering, quality, and related product teams to champion continuous improvement initiatives. Additionally, the software expedites time-to-market by facilitating collaborative workflows across engineering teams during the product development phase, thus minimizing approval cycles and accelerating the product launch process.
Ensuring Regulatory Compliance and Transparency
Arena's product-centric QMS serves as an invaluable tool for regulated life science companies, ensuring the interoperability of total engineering designs while aligning with evolving regulatory standards such as FDA, EU MDR, and ISO requirements. By speeding up engineering change processes and new product development, enhancing design efficiency, and bolstering traceability and transparency, Arena Solutions PLM reduces audit risks and fosters compliance with stringent industry regulations.