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This Implementer course gives learners a detailed understanding of ISO 13485:2016 and how to achieve certification. Topics covered include the requirements of a Quality Management System for Medical Devices (QMS for Medical Devices), its benefits, documented information, implementation techniques, and preparation for the certification audit.
The course is ideal for anyone who needs a thorough understanding of ISO 13485:2016, will be playing a key role in implementing and maintaining a QMS for Medical Devices at your company, and needs to know the steps required to achieve certification.
The ISO 13485 course includes an examination. Upon successful completion, graduates have the option to seek registration as an Exemplar Global Certified Medical Device Management System (ISO 13485) Specialist.
ISO 13485 implementer training and exam are online and on-demand. Both can be taken anytime and on any device.
On completion of the course you will:
The online course is interactive and combines videos with lectures, presentations, and practical examples. More than 200 pages of PDF handouts are provided, which learners are encouraged to retain and refer back to.
Overview of ISO 13485:2016
This first part introduces ISO 13485, explaining what it is, how it's used, and the purpose and benefits of a QMS for Medical Devices.
Principles of ISO 13485
The ISO 13485:2016 standard embraces 8 core principles: customer focus, the engagement of people (staff and managers) within the organization, strong leadership, continual improvement, evidence-based decision making, a process approach, a system approach to management, and relationship management.
Requirements of a Quality Management System for Medical Devices
This part takes a step-by-step look at the relevant clauses in the ISO 13485:2016 standard in order to understand what they mean and what your company needs to do to comply with them.
Control of Documents & Records
Clear, well-written, and non-bureaucratic documentation is an important part of a QMS for Medical Devices.
While documents are used for storing and sharing information, records are essentially hard copies of results (such as from an audit) or evidence of activities that have been performed.
And while documents get revised from to time and are generally kept up-to-date, records are static and never revised.
Risk Management
The ISO 13485 standard requires that risk-based thinking be a part of your Quality Management System's processes, and risk management be a key consideration with regards to patient and/or end-user safety when using a medical device.
Steps for Implementation & Certification
The final part examines the steps necessary to implement an ISO 13485 QMS for Medical Devices and achieve certification.
This course is ideal for:
Graduates of this ISO 13485:2016 Implementer Training course receive a Certificate of Completion with the Exemplar Global accreditation mark. The certificate provides evidence of successfully passing the training program.
To receive a Certificate of Completion, you need to pass the final exam. It's a multiple-choice assessment with a passing score of 60%. The exam can be re-taken unlimited times without additional charge.
Login credentials for course dashboard, handouts and course materials, and course certificate.
The course takes about 24 hours to complete (on-demand).
Technical support and access to an instructor are available when needed.
Buy without risk and get a full refund if you're not completely satisfied.
Access to this course is available immediately after payment for 3 months.
Works on PCs, tablets and smartphones. Windows, Mac, iOS and Android compatible.
Stephan Wald
26 September 2023
Overall it is a course I will strongly recommend. I would say there are small inconsistencies with the course structure, but these are minor and will ...
Keith Lim
26 February 2024
I am happy to give my feedback for this ISO 13485 training program for company implementers. I am the implementer for my company because senior ...
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Our courses include free materials and handouts you can download, keep, and refer back to.
Our self-paced learning allows you to stop and resume whenever you want and switch between any device.
(78)
USD 95.00
This course is brief (4 hours) but does a very good job of covering ISO 13485, its requirements and benefits, and explaining what a Quality Management System for Medical Devices means for your organization. A popular course that we strongly recommend.
(124)
USD 395.00
This Exemplar Global-certified course teaches learners the skills needed to audit their organization's ISO 13485 Quality Management System for Medical Devices. Topics include an overview of ISO 13485 and its requirements, documentation, implementation, auditing strategies and techniques, best practices and practical tips.
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