Medical Device: Risk Assessment and Mitigation through FMEA

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.

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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 Dev Raheja

Risk Management Consultant, Independent

Dev Raheja, MS,CSP, author of the books Safer Hospital Care and Design for Reliability, is an international risk management, patient safety and quality assurance consultant for medical device, consumer products, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for variety of systems.

Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management and the online faculty at University of Maryland where he teaches courses on Reliability and Safety . He is a Founding Fellow of American College of Healthcare Trustees and a member of American College of Healthcare Executives, He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners.

He serves on the Patient and Families Advisory Council at Johns Hopkins Hospital. He helped them in providing 24/7 access to family members of patients and reduced the number of alarms for nurses so they recognize critical patient needs early.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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