Presented by
Management Forum
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
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
- An Introduction to the Medical Device Regulation
- Introduction to the In-Vitro Diagnostic Regulation (IVDR)
- The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
- An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
- Managing Competence within the Medical Device Industry
- An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
- An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
- A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK
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
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
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.
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
Live online
09:00-16:45 UK (London) (UTC+01)
10:00-17:45 Paris (UTC+02)
04:00-11:45 New York (UTC-04)
Course code 14216
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 30 May
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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; and apply only when booking multiple delegates on the same date.
United Kingdom
- Almac Group
