Understanding ISO 13485 Requirements: Management Systems for Medical Devices
What exactly does ISO 13485 require? How should I implement it in my manufacturing plant? This course will answer these questions in detail using an entire Resources Section devoted to sample documents you can customize to your plant. 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.
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Groups: If 2 or more people from your organization are registering for this course, you can recieve 10% off. Use coupon code MULTI.
Who Should Attend
Those responsible for quality and risk management in the medical devices field
How You Will Benefit
Champion ISO 13485 plant benefits.
Describe ISO 13485 standard requirements.
List the steps to implement ISO 13485.
Prepare an action plan to get started.
Benefits of ISO 13845
Requirements for clauses 4-8
ISO 13845 implementation action plan
Attendees must purchase a copy of the standard ISO 13485:2016 Medical Devices – Quality management systems – Requirements for regulatory purposes and bring it to class. The standard may be purchased through the American National Standards Inst. (ANSI) and/or American Society for Quality (ASQ).
Notebook with Resources Section of sample documents
For Course-Related Questions
Please contact the course administrator: Carol Aton
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