Achieve regulatory compliance in medical device design

Medical device manufacturers must ensure compliance with the design control process to avoid audit issues, market delays and product recalls. Effective compliance is achieved through complete, relevant and up-to-date Design History Files (DHF) managed with our Design Control tools, facilitating model-based systems engineering and streamlining regulatory interactions. These tools enhance collaboration between R&D and production, maintain comprehensive Device Master Records (DMR), and manage data throughout the design lifecycle. The process includes project management, audit support, change control, and regulatory submissions, ensuring synchronized and compliant design data for efficient production and communication.

Read the ebook to see how Design Control for Medical Devices process compliance tools bring you the technology to transform the everyday and make your design operations more effective.