Professional Education Course
Understanding ISO 13485 Requirements: Management Systems for Medical Devices
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PDF version| Course Title: Understanding ISO 13485 Requirements: Management Systems for Medical Devices | |
| Program ID: QUAL 1117P | Subject: ISO Standards Training Courses |
Sections
| Registration Deadline | Section Dates | Format & Location | CEUs | Fee | Status |
|---|
| Sep 11, 2012 (Tue) | Sep 11, 2012 (Tue) - Sep 12, 2012 (Wed) | Atlanta (Georgia Tech Global Learning Center) (this is an onsite course) | 1.40 | $895 | OPEN |  |  |
| Apr 16, 2013 (Tue) | Apr 16, 2013 (Tue) - Apr 17, 2013 (Wed) | Atlanta (Georgia Tech Global Learning Center) (this is an onsite course) | 1.40 | $895 | OPEN | | |
Meeting Times
On the first day, check in at least 30 minutes before the class start time
- Tuesday, April 16, 2013 (8:30 AM-6:00 PM)
- Wednesday, April 17, 2013 (8:00 AM-5:00 PM)
CRN
13007/220413325| Oct 15, 2013 (Tue) | Oct 15, 2013 (Tue) - Oct 16, 2013 (Wed) | Atlanta (Georgia Tech Global Learning Center) (this is an onsite course) | 1.40 | $895 | OPEN | | |
Meeting Times
On the first day, check in at least 30 minutes before the class start time
- Tuesday, October 15, 2013 (8:30 AM-6:00 PM)
- Wednesday, October 16, 2013 (8:00 AM-5:00 PM)
CRN
13008/220414057Course Description
What exactly does ISO 13485 require? And how should I implement it in my manufacturing plant? Using an entire Resources Section devoted to sample documents you can customize to your plant, this course will answer these questions in detail. In addition, the course provides guidance on the ISO 13485 relationship with FDA regulations and similar requirements in Canada, Europe, and South America. If you are looking to expand your market overseas, this course will show you what doors are open to you.
How You Will Benefit
At the end of this course, learners will be able to:
- Champion the benefits of ISO 13485 at their plant
- Describe the requirements of ISO 13485, including those referenced within the standard
- List the common steps for implementation of ISO 13485
- Prepare an action plan to get started
What Is Covered
- Benefits of ISO 13485
- Document Overview
- Requirements for Clause 4
- Requirements for Clause 5
- Requirements for Clause 6
- Requirements for Clause 7
- Requirements for Clause 8
- International Relationships
- Implementation of ISO 13485 Action Plan
Course Materials
Attendees will each receive a notebook with Resources Section of sample documents and copy of ISO 13485 or equivalent.
Meeting Times
On the first day, check in at least 30 minutes before the class start time
CRN
12374/220413167