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

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 13485Learn how to develop a Quality Management System (QMS)Know your responsibilitiesComply with the regulatory requirementsTake part in workshop exercises to consolidate the knowledge gained

Who Should Attend

Quality managersQuality assurance personnelRegulatory affairs managersInternal and external auditorsMedical device designers and developersAll those who are involved with the implementation of the QMS

Agenda

Welcome and Introduction

Objectives for the dayWhat do you want from the day?

Overview of ISO 13485:2016

Introduction to standards and their useUse of ISO13485:2016Conformity assessmentCost/Benefit of Quality

Defining the Scope and Objectives of Your QMS

Quality policyQuality objectivesQuality manual

Documentation Requirements

RequirementsDocument controlResource managementTraining

Workshop Exercise: Writing Quality Policy and Objectives

Intellectual Property (IP) to CE Marking in a QMS

Design and development

Supplier Management

Economic OperatorsSupplier managementSupply chain control

Direct Processes

Change managementRisk ManagementControl of non-conforming product

Post Market Surveillance

What is it?The elementsReactive 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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