Course Title: CE Marking IVD 98-79 EEC Implementation and Auditing, Essential Requirements Only

CEU: 2.0

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:

General requirements I

Auditing questions for general requirements I
General requirements II

Auditing questions for general requirements II

General requirements III

Auditing questions for general requirements III

General requirements IV

Auditing questions for general requirements IV

General requirements V

Auditing questions for general requirements V

Design and manufacturing requirements

Chemical and physical properties

Auditing questions for chemical and physical properties

Infection and microbial contamination

Auditing questions for infection and microbial contamination

Manufacturing and environmental properties

Auditing questions for manufacturing and environmental properties

Devices which are instruments or apparatus with a measuring function

Protection against radiation

Auditing questions for protection against radiation

Requirements for medical device

Auditing questions for requirements for medical device

Requirements for devices for self testing

Auditing questions for requirements for devices for self testing

Information supplied by the manufacturer

Auditing questions for information supplied by the manufacturer

CE Marking IVD 98-79 EEC Implementation and Auditing, Essential Requirements Only 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.

QUALITY UNIVERSITY mark is a registered trademark and should not be used by any individual or companies without written approval of Quality University.

Computer configuration needed for the course:

• Microsoft Internet Explorer
• Make sure all Pop-Up Blockers are disabled, in other words, pop-ups are allowed
• If you have any other issues, please restart your computer
• 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

Corporate Accounts and Discounts:

Please find the link listed below to access the Corporate Form:

http://www.qualityuniversity.com/commerce/misc/other.jsp

• 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.

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.