AAMI 13485 2016

$112.02

AAMI/ISO 13485:2016 Medical Devices-A Practical Guide, Advice from ISO/TC 210

Published By	Publication Date	Number of Pages
AAMI	2016

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Category: AAMI

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Description

This document provides requirements and recommendations to writers of medical devicestandards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology. This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these. In this document, the term “product” includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.

PDF Catalog

PDF Pages	PDF Title
2	Blank Page
8	Foreword
12	Introduction
25	1 Scope
29	2 Normative references
31	3 Terms and definitions
33	4 Quality management system
61	5 Management responsibility
81	6 Resource management
95	7 Product realization
167	8 Measurement, analysis and improvement
211	Annex A — Guidance for small organizations
217	Bibliography