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To ensure patient safety, medical device manufacturers must establish and maintain quality systems to meet regulatory compliance requirements specified by the FDA, ISO, and other regulatory bodies. Adhering to regulations like the FDA’s 21 CFR part 820 and ISO 13485 are key to your commercialization success.
Arena’s cloud-based QMS software helps you achieve and maintain strong design controls. This simplifies the management of standard operating procedures (SOPs), device history files (DHFs), device master records (DMRs), training records, and the entire product record by linking all quality and product information throughout new product development and introduction.
Introducing a safe, compliant, and innovative medical device to market is no easy feat. In fact, it requires orchestration between your quality, engineering, and operations teams, along with your supply chain partners. Arena Quality Management System (QMS) software provides you with a single system of truth to develop and introduce devices, while eliminating compliance risks.
teams follow closed-loop quality processes to improve traceability
establishes strong design controls and ensures regulatory compliance
improve adherence to training records, SOPs, and more
gain visibility to continually improve compliant designs
can confidently prepare for and pass internal, ISO, or FDA audits
teams can make better decisions to speed commercialization
In a regulated environment, the key to introducing new products while maintaining compliance is connecting your product and quality records. Arena Solutions’ cloud QMS software provides a product-centric approach that links quality, training, supplier, and audit records to the entire bill of materials (BOM).
Learn how the seven principles of product-centric quality management simplify regulatory compliance.
Arena QMS enables medical device manufacturers of Class I, II, and III devices to address FDA 21 CFR Part 820, Part 11, and ISO 13485 requirements. We help you gain control of your DMR, DHF, SOPs, and training records to pass internal or FDA audits.
“Although the Arena team was not involved in our FDA inspection, your solution helped us find and retrieve records quickly to address inspection requirements ahead of schedule. Thank you for supporting our needs and creating a solution that really works as promised!”
Michelle J. Potvin ASQ CQA, Director, Quality Assurance & Regulatory Affairs, Swan Valley Medical
