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Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

Working with more than 200 medical device developers, Jama Software has established best practices for risk management in Jama Connect™.

This paper takes you through the main clauses of ISO 14971 — the FDA’s mandatory standard for risk assessment in medical devices — and outlines how Jama Connect gives you a comprehensive way to manage risk and requirements throughout development.

Learn how to:
  • Understand ISO 14971 and FMEA
  • Identify, analyze and mitigate risk
  • Connect risks and requirements
  • Achieve end-to-end traceability
  • Ease the path to compliance
Previous Flipbook
Jama Connect Risk Management Center
Jama Connect Risk Management Center

Read this datasheet to find out how to manage both risks and requirements directly within Jama Connect.

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Jama Connect™ Risk Management Center
Jama Connect™ Risk Management Center

An integrated solution for guiding medical device risk management.