Medical Device: Risk Assessment and Mitigation through FMEA

Why Should You Attend:

Failure modes and effects analysis (FMEA) can be a helpful tool in risk management for medical devices, but it has several inherent traps that should be recognized and avoided. The standard has been recognized by FDA, and in Europe through ISO 14971. Therefore compliance to this standard is crucial not only in assuring the safety and reliability of medical equipment, but in meeting regulatory requirements as well.

This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device. We will cover design FMEA and process FMEA procedure and show how this methodology can be used for even complex systems.

Learning Objectives:

Participants will learn

• The most widely used method for risk estimation.
• A structured way to mitigate risks with minimum cost.
• To develop a right test plan from FMEA.

Areas Covered in the Seminar:

• FMEA methodology-the right way for efficiency.
• Design FMEA Procedure.
• How to save over 50% time for conducting FMEA.
• Process FMECA Procedure.
• How to eliminate defects in manufacturing.
• How to design validation tests from FMEA.
• How to reduce costs from using FMEA.

Who Will Benefit:

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

Instructor Profile:

Dev Raheja, a respected and sought out expert on medical device and hospital care safety, draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and system reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. He applies analytical tools that can effectively measure efficiency, establish evidence between Lean strategies and customer satisfaction.

His focus is on using various types of innovations to encourage a culture conducive to high return on investment. He is the author of the books Assurance Technologies principles and Practices, and Safer Hospital Care. He has served as Associate Professor for the PhD degree in Reliability Engineering at University of Maryland during 1994-99.

Topic Background:

Between 1983 and 1997, 1 in 4 medical devices used software. Today, over 50% devices are run by software. Software governs everything from digital thermometers to pacemakers. The risks can be high and crashes can mean injury or death. A report recommends that the FDA develop procedures to ensure the safety and effectiveness of products before they go to market. This report concludes that many of the software-based devices — including some insulin pumps, infusion pumps that deliver medicine or food to patients intravenously, and defibrillators used in cardiac arrest — are cleared by the FDA through an accelerated process that involves little or no clinical testing. Therefore, companies must find their own way to assure robust validation.

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