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.