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An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course

An Essential Overview

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

4 July 2024
+ 20 November 2024 »

from £549

Need help?  Enrol or reserve

Overview

The ISO 13485:2016 standard specifies requirements for a Quality Management System (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Such medical device organisations can be involved in one or more stages of the life-cycle, including; design and development, production, storage and distribution, installation, or servicing of a medical device, and design and development or provision of associated activities such as technical support.

ISO 13485:2016 can also be used by suppliers or external parties that provide products, including QMS-related services to such organisations.

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.

Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

This course will be useful as a refresher or for those new to the medical device industry.  

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of Attending

  • Understand the requirements of ISO 13485
  • Learn how to develop a Quality Management System (QMS)
  • Know your responsibilities
  • Comply with the regulatory requirements
  • Take part in workshop exercises to consolidate the knowledge gained

Who Should Attend

  • Quality managers
  •  Quality assurance personnel
  • Regulatory affairs managers
  • Internal and external auditors
  • Medical device designers and developers
  • All those who are involved with the implementation of the QMS

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The An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices course will cover:

Welcome and Introduction

  • Objectives for the day
  • What do you want from the day? 

Overview of ISO 13485:2016

  • Introduction to standards and their use
  • Use of ISO13485:2016
  • Conformity assessment
  • Cost/Benefit of Quality 

Defining the Scope and Objectives of Your QMS

  • Quality policy
  • Quality objectives
  • Quality manual 

Documentation Requirements

  • Requirements
  • Document control
  • Resource management  
  • Training 

Workshop Exercise: Writing Quality Policy and Objectives

Intellectual Property (IP) to CE Marking in a QMS

  • Design and development 

Supplier Management

  • Economic Operators
  • Supplier management
  • Supply chain control 

Direct Processes

  • Change management
  • Risk Management
  • Control of non-conforming product 

Post Market Surveillance

  • What is it?
  • The elements
  • Reactive vs Proactive 

Workshop Exercise: Quality Management - Functional Interaction

Summary and Key Take Aways

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Stuart Angell
Ivdeology

Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.

He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

4 July 2024

Classroom
Rembrandt Hotel
London

08:30-16:45 UK (London)
Course code 14216
Optional £280 per night

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 30 May

  • 1 day classroom-based training
  • Optional accommodation - 1 night including breakfast, checking in the day before the course
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

20 November 2024

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
04:00-11:45 New York (UTC-05)
Course code 14217

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 16 Oct

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Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

United Kingdom

  • Almac Group

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy