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Risk Analysis Techniques

ISO 14971 says “manage risk.” But how do you analyze it?

Knowing these techniques is one thing.

Applying them across design, verification, and risk tracking is where Matrix Req shines.

It’s a ALM built to turn ISO 14971 into a practical, connected workflow into medical device design:

  • Manage risks in line with ISO 14971

  • Create tailored documentation based on your processes

  • Link risks to requirements, designs, tests, and issues

  • Track mitigation with clear before/after dashboards

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