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
Certifications
- CPD: 6 hours for your records
- Certificate of completion
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 LtdStuart 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.
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
