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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