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Course preparations


Course preparations

This page provides you with information to help you prepare for a course that you will be attending. Please click a link below to be taken to the relevant preparations. If you are interested, you can also access other course preparation pages below.


Project management for product development of medical devices

We recommend the following preparations in the below order of priority:

  1. Watch the video below (13 minutes of preparatory video course)
  2. Download and read the FDA Guidance document on design control

 

Design control for medical devices

We recommend the following preparations:

  1. Watch the video below (13 minutes preparatory video course)
  2. Download and read the FDA Guidance document on design control

Risk management for medical devices and ISO 14971

We recommend the following preparations:

  1. Watch the video below (30 minute introductory course to risk management)

Quality management and ISO 13485

There are currently no preparatory course material for this course.