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.
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-
- 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.