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Medical Device: Risk Assessment and Mitigation through FMEA
Tuesday, June 19, 2012 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
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.
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.
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:
- 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.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.