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ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. Organizations seeking certification must demonstrate not only understanding of the standard but effective implementation across all processes. A competent lead implementer is essential to navigate this complex undertaking.
This online Implementer training prepares you to lead that effort. You will learn how to interpret ISO 13485 requirements, develop necessary documentation, manage implementation projects, and prepare your organization for successful certification audits. Through a structured curriculum combining theoretical knowledge with practical resources, you will develop the competence to implement medical device quality management systems aligned with ISO 13485:2016.
The course is delivered entirely online and is self-paced, allowing you to progress through the material according to your own schedule. Upon successful completion, you will receive a certificate documenting your training as an ISO 13485 Lead Implementer.
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An effective implementer does more than simply document processes. They translate standard requirements into practical, workable systems that enhance quality and support regulatory compliance. A competent ISO 13485 implementer must be able to:
This course develops these capabilities through structured lessons, practical examples, and ready-to-use templates you can adapt for your organization.
The training is organized into six focused sessions that build your knowledge progressively. Sessions include:
Session 1: Overview of ISO 13485:2016
An introduction to the ISO 13485 standard – its purpose, scope, and position within the medical device regulatory landscape. You will understand who uses this standard, why certification matters, and how the standard relates to regulatory requirements.
What you'll learn: The role of ISO 13485 in medical device quality management and its relationship to global regulatory frameworks.
Session 2: ISO 13485:2016 Principles
An examination of the foundational principles that underpin effective quality management in medical device organizations. Topics include customer focus, leadership engagement, process approach, evidence-based decision making, and continual improvement.
What you'll learn: How the eight quality management principles apply specifically to medical device organizations and guide implementation decisions.
Session 3: ISO 13485:2016 Requirements
A comprehensive clause-by-clause review of the ISO 13485:2016 standard. You will examine each requirement in depth, understanding what constitutes compliance and what evidence is needed for certification. Particular attention is given to areas where organizations commonly need guidance during implementation.
What you'll learn: Detailed understanding of ISO 13485:2016 requirements and how to translate them into practical processes and controls.
Session 4: Control of Documents and Records
A focused examination of documented information requirements. You will learn the practical differences between documents (which are maintained and updated) and records (which are retained as evidence). The session covers document approval, distribution, version control, and retention requirements appropriate to medical device organizations.
What you'll learn: How to establish document control systems that meet ISO 13485 requirements without creating unnecessary bureaucracy.
Session 5: Risk Management
ISO 13485 requires risk-based thinking throughout the quality management system. This session explains how risk considerations apply to processes, products, and the QMS itself. You will learn to evaluate whether an organization has appropriately identified and addressed risks in areas such as supplier selection, design changes, and production controls.
What you'll learn: How to integrate risk management into QMS implementation and document risk-based decisions appropriately.
Session 6: Steps for ISO 13485 QMS Installation & Certification
The final session examines the complete implementation pathway, from initial gap analysis through certification audit. You will learn project planning, resource allocation, documentation development, internal audit preparation, and selection of a certification body.
What you'll learn: A practical roadmap for implementing ISO 13485 and achieving successful certification.
The course provides a comprehensive set of resources that support your learning during the training and serve as valuable references afterward:
This training is designed for individuals who need to lead or contribute to the implementation of an ISO 13485 quality management system. Typical participants include:
The course is appropriate for those new to implementation as well as experienced professionals seeking to formalize their knowledge of ISO 13485:2016.
Note: If you need to conduct internal audits or lead audit teams, the ISO 13485 Auditor Training or ISO 13485 Lead Auditor Training are more appropriate choices.
The training program includes six session exams and a comprehensive final examination. The assessments are in multiple-choice format and are designed to verify your understanding of the course material. To pass, you need a score of 60% or higher. If you do not pass on your first attempt, you may retake any exam at no additional charge.
Graduates receive a Certificate of Completion bearing the Exemplar Global accreditation mark. This certificate documents your successful completion of ISO 13485:2016 Implementer Training and successful completion of the examinations.
Certificates are issued in digital format upon passing the final examination. You may download, add to LinkedIn, and print your certificate directly from your course dashboard.
Complete course access including dashboard login, downloadable handouts, and certificate.
Self-paced learning – complete the 24 hours of content on your schedule.
Instructor access and technical support whenever you need assistance.
30-Day Money-Back Guarantee – enroll risk-free.
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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We are TPECS certified – a distinction held by only a select group of training organizations worldwide.
Career-Focused Training
Acquire practical skills you can apply immediately – and the certification to prove it.
Learning Resources
Courses include materials you can download, keep, and refer back to long after completion.
Learn on Your Schedule
Self-paced format lets you pause, resume, and switch between devices without losing progress.
Once enrolled, you have 3 months access to the course content (can be extended upon request). During this time you can complete the training at your own pace and return to review materials whenever you need to refresh your knowledge.
Course access ends upon successfully completing the final exam.
Yes. While there is no official "Lead Implementer" designation in the same way as Lead Auditor, this course covers all aspects of ISO 13485 implementation including the leadership skills needed to manage an implementation project.
The training prepares you to lead an implementation team, manage complex projects, and advise organizations on establishing an ISO 13485-compliant QMS.
The course includes ready-to-use sample documents that you can customize for your organization:
To derive maximum benefit from this training, participants should have a general understanding of quality management system concepts and familiarity with the Plan-Do-Check-Act (PDCA) cycle.
A solid understanding of these concepts is best obtained through our ISO 9001 training.
Prior experience with medical device regulations is helpful but not essential.
While we don't have a sample version of this ISO 13485 course available, you can try the entire course without risk! Your purchase includes our comprehensive 30-Day Money-Back Guarantee.
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