ISO 13485 Starter Guide

by Emmet Tobin

This short concise book provides an introduction to ISO 13485. It introduces the core themes of the standard to those who wish to work in regulated industries such as medical devices, highlighting key areas and practices. It is a perfect introduction for operators, factory workers, engineers and managers wishing to learn the fundamentals. It is also a useful pocket reference book, small enough to slip into a case or pocket.

ISO 13485 is the Quality management standard of choice for manufactures of medical devices.
Revised in 2016, ISO 13485:2016 “specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”1 The scope of the standard can apply to any organization or company involved in throughout the life-cycle of a product, including design and/or development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of technical or professional services.
(Page count 86 pages)

84 pages, Paperback

Published June 13, 2016

Reviews

[Douglas · Rating 3 out of 5]

A very brief overview of ISO 13485; a very preliminary introduction to set the scene for next steps of research and investigation.

[Nata · Rating 5 out of 5]

Nice start with good explanation

I liked this guide, it help to understand basic requirements with human language, not the one used in the standard...