Skip to Main Content

Manage safety, compliance and monitoring with Design Control for medical devices

Design control for medical devices is crucial for safety, compliance and monitoring throughout the product lifecycle. Along with risk management, design control is mandated by US 21 CFR Part 820 and EU MDR / IVDR regulations. However, implementing and enhancing this process can be challenging due to the amount of people and data involved in product design. Siemens' Design Control tools address these challenges by ensuring comprehensive digital traceability, efficient design file management and continuous monitoring.

Adopt a data-driven, model-based approach

Our solution empowers medical device manufacturers to adopt a data-driven, model-based and document-smart approach, enhancing engineering efficiency and preventing costly errors throughout the device lifecycle. Recognizing that design control is a cyclical process involving iterative actions and continuous improvements, our tools facilitate re-use and consistency, streamlining progress tracking and enabling a data-driven approach.

Read our ebook and learn how to make your design control process more effective to master safety, compliance and monitoring of your medical device design.