ISO 13485:2016

ISO 13485:2016 – Chapter 1-3: Introduction

The learning objectives of this program are to understand what ISO 13485 is, and what some of the key advantages to an ISO 13485 certification can provide. This program will also provide an in depth understanding of which policies, procedures and systems need to be put in place to be able to implement and maintain compliance with the 13485 standards.

CEU Credits: 0.1

Course Code: ELM-801

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Module 1: Introduction

Overview

Course introduction

CFR, ICH and The FDA

Challenges facing the medical device industry

Single user license

Course objectives

Module 2: About ISO

Background & history

Mission statement

The difference between ISO 13485 and ISO 9001

Updates every five years

ISO certification

Advantages of ISO certification

European Union – Part 1

European Union – Part 2

The United States

ISO inspections – Part 1

ISO inspections – Part 2

Module 3: Medical Devices – Quality Management System

Scope

Definitions

Definition example

Conclusion

Final Assessment

Certification

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