Home └TM 007 Medical Devices Quality Management System ISO 13485 2016
TM 007 Medical Devices Quality Management System ISO 13485 2016

TM 007 Medical Devices Quality Management System ISO 13485 2016


The ISO 13485 standard: 2016 specifies requirements for the medical device and quality management system to be used by related medical device companies.

The implementation of an appropriate QMS is essential for medical device companies.The global regulatory requirements insist on this point and oblige the respect of these standards by the companies all over the world. Along with this need for implementation comes a need to understand the requirements.
The aim of this course is to clarify the application of ISO 13485: 2016 standards for companies of medical device development of the medical device.

In this course we are going to walk through the ISO standard for:
- 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 familiar with best practice guidelines that will benefit 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 in accordance with medical requirements.Get the information you need to design, and improve your company's QMS in accordance with ISO 13485: 2016.

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

Are there any course requirements or prerequisites?
- 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

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

Private Course
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Responsible Franck BAROT
Last Update 01/19/2023
Completion Time 1 hour 56 minutes
Members 36
Staff
    • ISO 13485 : 2016 QMS Training - Section 1 : Introduction
      Preview 10 xp
    • ISO 13485 : 2016 QMS Training - Section 2 : Clause 1, 2, 3, 4
      10 xp
    • ISO 13485 : 2016 QMS Training - Section 2 : Clause 5, 6
      10 xp
    • ISO 13485 : 2016 QMS Training - Section 2 : Clause 7
      10 xp
    • ISO 13485 : 2016 QMS Training - Section 2 : Clause 8
      10 xp
    • ISO 13485 : 2016 QMS Training - Section 3 : Preparation of documentation
      10 xp
    • ISO 13485 : 2016 QMS Training - Section 4: Implementation
      10 xp
    • ISO 13485 : 2016 QMS Training - Section 5 : Verification of implementation
    • ISO 13485:2016 Training Certificate
    • Evaluation of trainer/training
    • ISO 13485 : 2016 QMS Training - PowerPoint