Revolutionizing Quality Management in the Medical Device Industry
Medical device manufacturers face increasing challenges to bring compliant products to market. The evolving regulatory standards demand meticulous attention to quality and compliance. Arena QMS, a Quality Management System software, offers a comprehensive solution to simplify compliance processes, reduce risks, and expedite product launches. By connecting quality management with product development, Arena QMS ensures transparency, traceability, and compliance throughout the entire new product introduction lifecycle.
Streamlined Quality Processes for Enhanced Compliance
Arena QMS serves as a single source of truth for managing quality records such as DMRs, DHFs, SOPs, and CAPAs in conjunction with product records like items, BOMs, and AML/AVL. This integration facilitates closed-loop quality management processes, reducing audit risks and enabling continuous improvement. With Arena Training, organizations can track and manage employee training plans to demonstrate competence in adhering to standards, instructions, and procedures.
Driving Product Innovation with Reliable Testing
Quality assurance teams benefit from Arena QMS's ability to synchronize inspection tests with product revisions, integrating seamlessly with quality control, CRM, and manufacturing execution systems. By enabling teams to define, revise, and review test specifications efficiently, Arena QMS promotes the development of safe, innovative, and compliant products. Medical device manufacturers can accelerate their product launch journey, navigating through 510(k) submissions and premarket approvals effectively.
Ensuring Regulatory Compliance and Efficiency
Arena QMS empowers quality teams to unify quality and product processes, ensuring better control and traceability. By identifying and resolving issues through closed-loop corrective and preventive actions (CAPA), organizations can maintain compliance with FDA regulations such as 21 CFR Part 820, Part 11, along with ISO 13485 and EU MDR standards. Additionally, adherence to cGMPs and software validation regulations further reduces risks and ensures operational efficiency.