ISO 13485 2016 Medical Device Checklist

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.

Attention

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

Title 45 Contents

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MORE ISO 13485 2016 PAGES

Introduction to ISO 13485 2016

Outline of ISO 13485 2016 Standard

Overview of ISO 13485 2016 Standard

ISO 13485 2016 versus ISO 13485 2003

Plain English ISO 13485 2016 Definitions

ISO 13485 2016 Translated into Plain English

ISO 13485 2016 Quality Management Gap Analysis

ISO 13485 2016 Quality Management Audit Program

Skills and Knowledge Internal Auditors Should Have

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Updated on May 16, 2016. First published on June 30, 2015.

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