August 9, 2013

Using Traceability to Identify Safety-related Requirements in Medical Device Development

Helix ALM
Requirements Management
When you're contemplating new features for a device or dealing with the need to change existing requirements, the impact on hazards and risk mitigation can often get lost in the shuffle. If adequate traceability is not maintained throughout the design control process, it can be challenging to identify what risks will be impacted if a specific requirement is added or modified. In the following video, which is a short excerpt from our recent Leveraging Traceability in Your Risk Management Strategy webinar, Michael Sieve walks through a TestTrack matrix report that makes identifying links between requirements and risk artifacts very straightforward.