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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.
Complete course access including dashboard login, downloadable handouts, and certificate.
Self-paced learning – complete the 24 hours of content on your schedule.
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Instant access after enrollment with 3 months to complete.
Learn on any device – Windows, Mac, iOS, or Android.
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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