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

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Dec 22, 2023, 06:00 ET

DUBLIN, Dec. 22, 2023 /PRNewswire/ -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.

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.

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

Agenda

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

Speakers:

Stuart Angell
Director
IVDeology Ltd

Stuart Angell, This MDTI expert 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.

For more information about this conference visit https://www.researchandmarkets.com/r/2hvkpa

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