Course Title: FEMA, Risk Analysis for Medical Devices

CEU: 0.4

Prerequisites:  None

Course Time Period:

You can take training at your own pace. You can logon and logout as many times as needed. You can re-take the exam as many times as necessary until you pass the exam and an online certificate is issued.

Key Session Topics:

Introduction Risk Analysis Techniques
What is FMEA?
When should FMEA begin?
At what stage should FMEA begin?
What are the various types of FMEA?
What is Risk Management?
What are the elements of the FMEA?
When is the Risk Assessment Matrix created and reviewed?
What are the Product Life Cycle Phases?
What is Stage 1 - Concept Design Phase?
What is Stage 2 - Development Phase?
What is Stage 3 - Validation Test Phase?
What is Stage 4 - Process Phase?
Failure Mode & Effects Analysis Worksheet
What are the steps for creating a FMEA Risk Assessment Matrix?
What are examples for Severity Rating S?
What are examples on how to calculate O Occurrence?
What are examples on how to calculate D Detection?
How to calculate RPN Risk Priority Number?
Risk Evaluation
What needs to be done if RPN > Acceptable Level
Risk concepts applied to medical devices
   Risk Estimation
   Probability Estimation
   Probability Severity Levels
   Risk Acceptability
   Cause of Failure

FEMA, Risk Analysis for Medical Devices Final Exam

Certificate Issuance: Online Certificate is issued upon completion of course and Final Exam

Courses Approval: All courses are approved by Quality University and the certificate issued has Quality University registered mark and certificate number.

Please follow instructions below for taking the course:

• Make sure you create a separate login account for each person taking the course. The name on the account should match the name of the person who is taking the course and whose name will appear on the certificate. Once created the contact name cannot be changed and the course cannot be reassigned to a different name.
• Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
• Select your course.

You can logon and logoff as many times as needed until the course is complete. In order to continue a course already in progress after you have logged off:

• log into Quality University through by clicking the "My Account" link
• Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
• Select your course. You may take the course and exam at your leisure.

You may retake the exam as many times as needed until a passing score is achieved.

For additional questions, you may contact us at our Help/Support Link located on the bottom of the Homepage.

Once you complete the course with a passing score on the exam you will be issued a certificate. Please print this cerificate for your own records. If you need to reprint a certificate for any reason, visit the "My Courses" link and you will have an option to reprint a certificate for any training you have completed.

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• Microsoft Internet Explorer
• Make sure all Pop-Up Blockers are disabled
• For any troubleshooting, refer to Help/Support at:http://www.qualityuniversity.com/commerce/misc/onsite.jsp
• If screen is blank, exit Internet Explorer and log back in again

• log into Quality University through by clicking the "My Account" link
• Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
• Select your course. You may take the course and exam at your leisure.

Please follow instructions below for taking the course:

• Make sure you create a separate login account for each person taking the course. The name on the account should match the name of the person who is taking the course and whose name will appear on the certificate. Once created the contact name cannot be changed and the course cannot be reassigned to a different name.
• Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
• Select your course.

You may retake the exam as many times as needed until a passing score is achieved. All courses are approved by Quality University and ISO Accelerate Group.

For additional questions, you may contact us at our Help/Support Link located on the bottom of the Homepage.

Once you complete the course with a passing score on the exam you will be issued a certificate. Please print this cerificate for your own records. If you need to reprint a certificate for any reason, visit the "My Courses" link and you will have an option to reprint a certificate for any training you have completed.