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Our Plain English standard can also be used as a Checklist. That's because we’ve used a task oriented approach to translate the original ISO 13485 2016 standard into Plain English. This means that our product (Title 45) consists entirely of tasks. So if you want to implement the ISO 13485 standard, all you have to do is carry out the tasks that we have listed. As you study these tasks you may realize that you’ve already performed some of them. In order to help you keep track of what you’ve already done and what you still need to do to meet the ISO 13485 requirements, we’ve provided a way of recording this information. To the right of each task you'll find a space that you can use to record your organization's status. For each task, you could record a DONE, TODO, or an N/A. Or you could simply enter a checkmark to indicate that a task has been or is being performed or an O/S to indicate that an item is outstanding.

Use our ISO 13485 2016 Checklist (Title 45) to establish your organization's quality management system and then use this system to show that you are consistently capable of providing medical device products and services that meet customer expectations and comply with all applicable regulatory requirements. Our Title 45 is 109 pages long. It is detailed, accurate, and complete, and uses language that is clear, precise, and easy to understand. We guarantee it!
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PRAXIOM RESEARCH GROUP LIMITED Phone: 780-461-4514 - info@praxiom.com
Updated on April 16, 2021. First published on June 30, 2015.