Medical Devices Quality Management Systems
This interactive and engaging online course has been designed to provide an in-depth understanding of ISO 13485:2016.
Trainingonline4U Ltd
Summary
- Certificate of completion - Free
- Exam(s) / assessment(s) is included in price
Add to basket or enquire
Overview
The publication of ISO 13485:2016 marked a turning point in Quality Management Systems for those involved in the lifecycles of Medical Devices.
ISO 13485:2016 was written to support Medical Device manufacturers in designing Quality Management Systems (QMS) that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery of Medical Devices that are safe for their intended purpose. ISO 13485 was last reviewed in 2020, maintaining that the 2016 version was still current.
This interactive and highly engaging online course has been re-designed to provide an in-depth understanding of ISO 13485:2016 and its practical implications. Learners will discover new knowledge and skills through a range of interactive learning methods including scenarios and regular knowledge checks. On completion of this training, participants will be able to apply their knowledge to the development of an ISO 13485:2016 compliant Quality Management System and help maintain ongoing certification for their organisation.
CPD
Course media
Description
Course Contents:
Module 1- Intro to ISO 13485
What is a Medical Device?
Introduction to ISO 13485
Scope of ISO 13485
Key Improvements from the 2003 Version of the Standard
Module 2- Quality Management Systems (QMS)
QMS General Requirements
What is an ISO 13485-compliant QMS?
QMS Document Requirements
Module 3- ISO 13485 Practical Implications
Management Responsibilities
Resource Management
Product Realisation
Measurement, Analysis and Improvement
Module 4- Summary
Course Summary
Knowledge Consolidation - Scenario
Knowledge Check - Exam
Who is this course for?
Explore the requirements of ISO 13485:2016 and how to apply this Standard in your own organisation. This course is suitable for anyone working in any phase of the Medical Device development lifecycle.
Career path
On completion of this training, participants will be able to apply their knowledge to the development of an ISO 13485:2016-compliant Quality Management System and help maintain ongoing certification for their organisation.
Questions and answers
Currently there are no Q&As for this course. Be the first to ask a question.
Certificates
Certificate of completion
Digital certificate - Included
Reviews
Currently there are no reviews for this course. Be the first to leave a review.
Add to basket or enquire
Course provided by
Legal information
This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.
