Course Title: CE Marking (90/385) for Active Implantable Medical Devices- Implementation and Auditing

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:

Introduction

The exceptions

Devices intended for special purposes

Penalties for non-compliance

Free marketing

Dimensions and locations of the CE Marking

Need for directives

Benefits for patients and users

What the auditor looks for during CE Marking audit

Key auditing questions

What the auditor looks for during all the audits

General description

Drawing

Operating principle

Essential requirements checklist under MDD

Risk analysis

Test results

Instructions for use

Device description

Manufacturing information

Risk summary

Validation reports

Essential requirements checklist

Complaint handling

Third party approvals

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

Requirements regarding design and construction

Auditing questions for requirements regarding design and construction

CE Marking (90/385) for Active Implantable Medical Devices- Implementation and Auditing 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.

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.