The Use and Mis-use of FMEA in Medical Device Risk Management

This 90-minute webinar will cover the best industry practices for Failure Modes and Effects Analysis (FMEA). You will learn what mistakes to avoid, how to reduce design and manufacturing defects, and how to implement risk management efficiently.

Why Should You Attend:

FMEA is one of the most important tools for risk management according to the ISO 14971 standard because it identifies known and unknown risks very early when the cost of reducing risks is very low. It can reveal missing requirements, vague requirements, missing functions, and point out component and manufacturing problems well before process validation. These in turn reduce life cycle costs and reduce the time to market. But, the tool has several inherent traps that should be recognized and avoided.

Areas Covered in the Seminar:

• How FMEAs are usually mis-used in medical devices?
• How to get most value from FMEAs.
• The correct way to conduct FMEA.
• How to integrate FMEA in the risk management process.
• Eliminating design defects to reduce risks of recall.
• Eliminating manufacturing defects to reduce risk of recall.
• A new strategy for getting fast results.

Who Will Benefit:

• Design engineers and managers
• Manufacturing engineers and managers
• Maintenance engineers and managers
• Risk Managers
• Compliance Officers
• Legal Professionals
• Senior Management
• Quality Control/Quality Affairs
• Regulatory Affairs
• Internal Auditors
• Operations/Production