หลักสูตร ISO 14971 Medical Risk Management

ISO 14971 Medical Risk Management

Course Description

Manage risk effectively and see business success with our ISO 14971 Medical Risk Management Training Course – an essential and international accreditation for all medical device manufacturers.

The ISO 14971 standard outlines how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle and we can help you implement a risk management framework to achieve ongoing compliance

Course Description

Manage risk effectively and see business success with our ISO 14971 Medical Risk Management Training Course – an essential and international accreditation for all medical device manufacturers.

The ISO 14971 standard outlines how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle and we can help you implement a risk management framework to achieve ongoing compliance

Course Benefits

$1·         Be confident your medical devices are ISO 13485 compliant

$1·         Ensure compliance continues throughout product lifecycle

$1·         Gain competitive advantage with ISO 13485 accreditation

$1·         Increase market access and customer confidence 

$1·         Encourage professional development and build risk awareness.

Learning Objectives

Upon completion of this training, participants will be able to:

$1·         Understand the importance and purpose of ISO 13485

$1·         Identify the links between ISO 13485 and ISO 14971

$1·         Learn how risk management applies to the product lifecycle

$1·         Define risk management terminology and objectives

$1·         Outline and lead the ISO 13485 risk management process

$1·         Gain CPD points and professional recognition

Intended Audience

$1·         Those working in regulation, quality, development and design

$1·         Those working in manufacturing and marketing

$1·         Those responsible for management system strategy decisions

$1·         Internal auditors

Course Duration

2 day

Prerequisites

There are no formal prerequisites, but it is recommended that you have a good understanding of your organization and its operations.

Further Information

A certificate of attendance is awarded to participants on this course.

 

Agenda

Day 1

Time

Topic

09.00

Welcome and Introductions

 

Course Aims, Objectives and Structure

 

Risk management terms and definitions

 

Regulatory requirements (MDD, AIMDD, IVDD)

 

Risk management and the QMS

 

EN ISO 14971: Overview of structure and contents

 

Risk management process: overview

 

Risk management techniques: Brief overview

17.00

Summary

Day 2

Time

Topic

09.00

Day 1 Review

 

Risk management process: Step by step

 

Risk analysis

 

Risk evaluation

 

Risk control

 

Evaluation of overall residual risk

 

Risk management report

 

Production and post-production information

 

Summary and questions

17.00

Close course

Two short breaks will be taken at suitably convenient times in the morning and afternoon. Forty five minutes will be given for a lunch break. Additional breaks may be taken as long as agreed by delegates and tutor, and all learning objectives are met.

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