A level of risk exists with all medical devices, no matter how simple they are. Companies developing medical devices are constantly considering who (or what environment, facility, etc.) could potentially be hurt by a device so they can help reduce risk and meet regulatory requirements. Risk management in the context of ISO 14971 is designed to support medical device manufacturers with these tasks — but not all approaches are created equal.

The amount of time it takes to manage risks, connect specific risks to specific requirement tasks and pull together required documents to respond to an audit varies slightly depending on the approach. The risk management process is an integrated process that not only includes teams in product development, quality, but also many other parts of an organization.

In this whitepaper, we tap into the knowledge of industry and solution experts to uncover:

• Best practices for integrated risk management
• How to integrate risk-based thinking into product development cycles
• The importance of having end-to-end traceability to improve risk management