Simplify FDA, EU MDR, and ISO Compliance
Medical device manufacturers are tasked with ensuring patient safety by meeting stringent regulatory compliance requirements from organizations like the FDA, EU MDR, and ISO. Achieving and maintaining compliance with regulations such as FDA's 21 CFR part 820 and ISO 13485 is crucial for the success of commercializing medical devices. Arena Solutions PLM offers a cloud-based Quality Management System (QMS) software that facilitates the establishment of strong design controls, simplifying the management of standard operating procedures (SOPs), device history files (DHF), device master records (DMR), training records, and the overall product record. By linking all quality and product information throughout the new product development process, Arena's QMS software helps manufacturers streamline compliance.
Connected Quality Processes
In a regulated environment, connecting product and quality records is essential for introducing new medical devices while maintaining compliance. Arena's cloud QMS software takes a product-centric approach by linking quality, training, supplier, and audit records to the entire bill of materials (BOM). This connectivity optimizes closed-loop quality processes, reduces internal and external audit risks, and simplifies software system validation. By following the seven principles of product-centric quality management, medical device manufacturers can enhance regulatory compliance efforts and improve overall quality control.
Face Audits with Confidence
Arena Solutions PLM empowers medical device manufacturers dealing with Class I, II, and III devices to meet the requirements of FDA 21 CFR Part 820, Part 11, and ISO 13485. By centralizing control over design master records (DMR), device history files (DHF), SOPs, and training records, manufacturers can confidently face internal and FDA audits. The system offers support and tools to help manufacturers quickly find and retrieve necessary records, ensuring compliance with inspection requirements and facilitating a smoother audit process. Customers like Michelle J. Potvin from Swan Valley Medical have praised Arena for its effective support and functional solutions that aid in compliance and quality assurance efforts.