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Best Practices for Improving Risk Management Using FMEA

Failure Modes and Effects Analysis (FMEA), is a common and trusted risk assessment tool used by systems and product development teams. If used effectively, FMEA can help teams identify and manage risk early, preventing costly late-stage changes. Unfortunately, many QA and development teams rely on spreadsheets and lengthy meetings to manage risk and hazard analysis, which can be cumbersome and disconnected from the development process. There is a better way.

Join Bethany Quillinan, Senior Quality Systems Consultant with Oregon Bioscience Association, and Joel Hutchinson, Senior Product Manager at Jama Software as we discuss how to define, manage, and improve your FMEA process to make risk management easier. We’ll demonstrate how to integrate risk and hazard analysis into the product definition and design process to ensure visibility into risk-related requirements and mitigations.

In this webinar, we’ll discuss:

  • Overcoming common pitfalls and challenges of risk and hazard analysis
  • Taking a team-based approach to FMEA that’s proactive, not reactive
  • Integrating risk analysis with requirements throughout the development process to improve alignment and mitigation
  • Aligning with industry best practices using FMEA templates
Previous Flipbook
Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971
Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

Tips for Medical Device Companies, Interested in Risk Techniques following ISO 14971, ISO 13485, FMEA, FTA,...

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Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device
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