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Develop the expertise to implement and maintain a medical device quality management system with the ISO 13485:2016 Implementer Training. This accredited online course prepares you to understand ISO 13485 requirements, manage documented information, apply implementation techniques, and ensure your organization is ready for certification audits.
Ideal for professionals responsible for implementing or maintaining a QMS for medical devices, the course includes the Implementer exam, with the option to register as an Exemplar Global Certified ISO 13485 Specialist. Training and exams are 100% online, on-demand, and accessible on any device.
Access the full course today, and if you're not satisfied within 30 days, get a full refund – no questions asked.
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.
Laura Mitchell
15 January 2025
I found the course incredibly well-structured, with clear videos and detailed handouts that broke down the standard into manageable pieces. The focus on risk management ...
Ava Rodriguez
10 May 2025
This course exceeded my expectations. The content on ISO 13485 requirements was thorough, and the real-world examples helped me see how to apply them in ...
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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.
(147)
USD 125.00
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.
(228)
USD 495.00
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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