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Show / Hide Details Interpret All Clauses of ISO 13485:2003 Recognize the basic requirements of 13485:2003 Learn the Benefits of Implementing ISO 13485:2003 Understand Differences between ISO 13485:1996 and ISO 13485:2003 Understand the Role of Management in ISO 13485:2003 Implementation Recognize the Relationship between Risk Management and ISO 14971:2001 Understand the Linkage between ISO 13485:2003 and GMPs Quality managers in the medical device industry Individuals who seek an understanding of the key concepts of ISO 13485:2003 Individuals involved in the transition from ISO 13485:1996 to ISO 13485:2003 Cross functional team members implementing ISO 13485:2003
Course Name
OL-MDM-OV13485: Recorded Webinar - Overview of ISO 13485:2003Slides
IMPORTANT: This is a recorded webinar.
Note: This course is free for BSI Internal Employees
The recorded version includes both Audio and the Web Conferencing Video.
Note: This course is free for BSI Internal Employees
The recorded version includes both Audio and the Web Conferencing Video.
Description
BSI’s “Recorded Webinar - Overview of ISO 13485:2003” gives students a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485:2003. Students learn how ISO 13485:2003 helps organizations improve their ability to meet customer and regulatory requirements and enhance the quality and safety of their products. In addition, students gain an introduction to the concept of risk management as described in the standard ISO 14971:2001, “Application of Risk Management to Medical Devices.” An experienced BSI instructor provides examples and real world experience, while students are encouraged to ask questions specific to their organizations.
Prerequisite
Students should have a basic understanding of medical device manufacturing before taking this course.
Topics Covered
Who Should Attend
Course Timing
This recorded version takes about 2 hours to complete.
System Requirements
An internet connection with at least Microsoft Internet Explorer 5 or Netscape 5. Also, Corporate Firewalls may prevent the dowload of the MP3 Audio file which can cause the course to hang. Only your IT department can determine if MP3's are being blocked.
Certificate of Completion
Please contact BSI (solutions.msamericas@bsi-global.com) to obtain a Certificate of Completion.
A certificate will only be provided to each individual person who has purchased a seat for the recording.
A certificate will only be provided to each individual person who has purchased a seat for the recording.
Slides
Softcopy slides are available after registration by clicking on the Course Attachment icon in the Action column for the course.
NOTE: E-Learning courses are typically available immediately upon enrollment.
| Course Duration | Course Fee | |
|---|---|---|
| 0 Days | USD $75.00 | Please log in to enroll. |
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