Using Polarion for Design Control of Medical Devices

Using Polarion enables organizations to address the key challenges in developing and certifying medical devices for commercial use; it also allows them to establish traceability from requirements, regardless of the software used.

Customers rely on Polarion to help them accelerate time-to-market for medical device innovation.

This whitepaper offers an overview of the nuances of requirements management, risk management, and mitigation, while also:

• Highlighting the shortcomings of traditional tools in addressing these challenges
• Providing a solution for the complex nature of medical device manufacturing