White Paper: Integrating Risk Management and IEC 62304 into Agile Development
What You'll Learn
Managing risk in regulated environments like medical device development can’t be a one-time task. Traditional waterfall methods treat risk analysis as a checkbox—Agile demands something more flexible, responsive, and audit-ready.
This guide shows how your team can integrate continuous, standards-aligned risk management directly into Agile workflows—without sacrificing speed or safety.
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Why Risk Isn't a One-and-Done Exercise
Learn how to treat risk documentation as a living artifact, not a static report.
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Applying IEC 62304 in Agile
Understand how to classify software components (Class A/B/C) and scale development rigor accordingly.
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Managing SOUP with Confidence
Get best practices for handling third-party and open-source components safely and transparently.
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Isolation and Segregation Strategies
See how smart architecture can contain risk and simplify testing and validation.
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