Medical Device Management Guide

NEW ISO 13485 2016 GUIDE

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 Checklist

Plain English ISO 13485 2016 Gap Analysis Tool

ISO 13485 2016 Quality Management Audit Program

Skills and Knowledge Internal Auditors Should Have

OBSOLETE ISO 13485 2003 GUIDE

Introduction to ISO 13485 2003 Standard

ISO 13485 2003 Quality Management Definitions

Outline of ISO 13485 2003 Medical Device Standard

ISO 13485 2003 Standard Translated into Plain English

ISO 13485 is a quality management standard for medical devices.
Use it to establish a quality management system for the design,
development, production, and installation of medical devices
and related services. Use it to become certified (registered)
and to demonstrate your ability to supply medical devices
and related services that meet customer requirements.



ISO 14971 RISK MANAGEMENT GUIDE

Introduction to ISO 14971 Risk Management

Overview of Medical Device Risk Management Standard

Plain English Medical Device Risk Management Definitions

Medical Device Risk Management Standard in Plain English

ISO 14971 is a risk management standard for medical devices. It defines
a set of risk management requirements. The purpose of ISO 14971 is to help
manufacturers to establish a medical device risk management process that
they can use to identify hazards, to estimate and evaluate risks, and to
implement and monitor the effectiveness of risk control measures.

MORE MANAGEMENT GUIDES

Our Process Management Guide

ISO 14001 2015 Environmental Guide

ISO 31000 2009 Risk Management Guide

ISO 9001 2015 Quality Management Guide

ISO 9004 2009 Quality Management Guide

ISO IEC 20000 Service Management Guide

ISO 19011 Management System Auditing Guide

ISO 90003 Software Quality Management Guide

AS9100D Aerospace Quality Management Guide

OHSAS 18001 Occupational Health & Safety Guide

ISO 27001 Information Security Management Guide

ISO 22301 Business Continuity Management Guide

ISO 28000 Supply Chain Security Management Guide



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