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Medical Devices Quality Management System - ISO 13485:2016
Rating: 4.3 out of 5(1,021 ratings)
2,476 students

Medical Devices Quality Management System - ISO 13485:2016

Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS.
Created byStendard Academy
Last updated 5/2020
English
English [Auto],

What you'll learn

  • How ISO 13485 requirements apply to medical device companies
  • Requirements of the ISO 13485:2016 standard
  • The importance of implementing a Quality Management System per ISO 13485:2016

Course content

5 sections • 9 lectures • 1h 31m total length

  • Introduction to ISO 13485:20167:45

    Introduction to the course, with a brief overview of the Quality Management System (QMS) implementation and ISO 13485:2016 certification process.

Requirements

  • No specific prior knowledge is required
  • Familiarity with quality management systems is helpful
  • A general understanding of medical device life-cycle is useful
  • Owning the ISO 13485:2016 standard is optional but recommended

Description

The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies.

Having a proper QMS in place is essential for medical device-related companies. Global regulatory requirements emphasise this and make it mandatory for such standards to be adhered to by companies worldwide.

With this need for implementation, comes a need for understanding of the requirements.

The purpose of this course is to clarify the application of ISO 13485:2016 standards for medical device companies and development of the medical device.


In this course, we will walk through the ISO 13485:2016 standard to:

  • Clarify on the concepts

  • Show how it relates to business processes

  • Elaborate on the practical application

You can learn what the requirements are, and be aware of best practice guidelines that are beneficial to your operations.

Furthermore, you can begin preparing your relevant set of documents (Quality Manual, SOPs, etc) for immediate implementation of your SOPs.


Understand and implement a best-practice Quality Management System as per requirements for the medical industry.

Get the information you need to design, coordinate and improve your company's QMS as per ISO 13485:2016.



Who this course is for:

  • Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
  • Professionals tasked with overseeing a management system meeting ISO 13485 standards
  • Quality managers
  • Risk managers
  • Medical device practitioners interested in the ISO 13485 framework

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