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.
★★★★★"I really liked the webinar, I have no complaint about it, just keep it up. The best for me was that ... more"
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.
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
Linda Garrod is a Quality Specialist at IVDeology Ltd, based in Kent, UK. She brings her exceptional quality experience from 20 years within the medical device industry, to support manufacturers in the creation and continual improvement of Quality Management Systems, compliant with the demands of ISO 13485, MDSAP and CE IVDR.
* 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.
Reviews of IPI's An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices training course
I really liked the webinar, I have no complaint about it, just keep it up. The best for me was that [speaker] is always open for questions; if there's any doubt about the topic explained.
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