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ISO 13485 affects much more than the quality department. Its requirements reach into design and development, purchasing, production, supplier control, complaint handling, and other activities across the medical-device lifecycle. Without a clear overview, those requirements can feel like disconnected rules and paperwork.
This Foundation course puts the pieces together. You will learn what ISO 13485 requires, why those requirements matter, how documentation and regulatory expectations connect to the QMS, and what organizations do to implement the standard and achieve certification.
It is designed for people who need a useful working overview without specialist implementer or auditor training. Complete the course entirely online and at your own pace, then pass the included final examination to earn your Certificate of Attainment.
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If the course is not right for you, request a full refund within 30 days, provided you have not completed it.
This course gives you the context to understand discussions, decisions, and responsibilities involving an ISO 13485 QMS. Upon completion, you will:
Four focused sessions build your understanding progressively. The course includes:
Session 1: Overview of ISO 13485:2016
An introduction to the ISO 13485 standard – its purpose, scope, and position within the medical device industry. You will understand who uses this standard, why certification matters, and how the standard relates to regulatory requirements around the world.
What you'll learn: The role of ISO 13485 in medical device quality management and the benefits of implementation.
Session 2: ISO 13485:2016 Requirements
A clear, clause-by-clause overview of the ISO 13485:2016 standard. You will examine each major requirement and understand what it means in practical terms for medical device organizations. This session provides the essential knowledge needed to understand compliance expectations.
What you'll learn: The key requirements of ISO 13485 and how they apply to different types of medical device organizations.
Session 3: Documented Information
A focused look at the documentation requirements of ISO 13485. You will learn the important distinction between documents (which are maintained and updated) and records (which are retained as evidence). The session covers what documentation is typically required and why proper control is essential.
What you'll learn: What documentation is needed for an ISO 13485 quality management system and how it should be controlled.
Session 4: Steps for Implementation & Certification
The final session explains the pathway to ISO 13485 certification. You will learn about the typical steps organizations take – from initial gap analysis through to the certification audit – and understand what is involved at each stage of the process.
What you'll learn: How organizations implement ISO 13485 and what to expect during the certification process.
This course is for people who need to understand ISO 13485 as a whole but are not responsible for implementing or auditing the entire QMS. It is particularly suitable for:
No prior knowledge of ISO 13485 is required. The course begins with the fundamentals and builds toward implementation and certification at an overview level.
Foundation Training is not a prerequisite for our role-specific courses. Learners who will implement or audit the QMS can go directly to the training for that role.
Short session exams help you check your understanding as you progress. The course concludes with a multiple-choice final examination covering the material taught throughout the program. A score of 60% or higher is required to pass, and you may retake any exam as often as needed at no additional charge.
After passing the final examination, you receive a Certificate of Attainment documenting your ISO 13485 Foundation training. It can serve as a training record for your employer and demonstrate your commitment to understanding medical-device quality management.
The certificate bears the IACET accreditation mark, and the course awards 0.4 IACET CEUs.
Your certificate is issued digitally and is available immediately from your course dashboard. You may download it, print it, and add it to your LinkedIn profile.
Need to give several people a consistent understanding of ISO 13485? Our platform makes it simple to purchase multiple seats and manage training across your organization.
Whether you’re training colleagues in one team or across several departments, the manager dashboard gives you full visibility without chasing emails or spreadsheets.
Course access, materials, certificate plus manager dashboard for bulk enrollment.
Self-paced learning – fit the 4-hour program into your schedule without disrupting business.
Instructor access and technical support whenever you need assistance.
30-Day Money-Back Guarantee – enroll risk-free.
Instant access after enrollment with up to 3 months to complete.
Learn on any device – Windows, Mac, iOS, or Android.
Madison Hayes
August 3, 2025
The ISO 13485 Foundation Training was an outstanding introduction to the standard! Incredibly accessible yet packed with valuable insights. The videos were engaging, and the ...
Sofia Almeida
April 20, 2025
This foundation course was perfect for getting started with ISO 13485. The content was clear, and the examples helped me see how the standard applies ...
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Acquire practical skills you can apply immediately – and the certificate to prove it.
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Courses include materials you can download, keep, and refer back to long after completion.
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Self-paced format lets you pause, resume, and switch between devices without losing progress.
Once enrolled, you have up to 3 months to complete the course. Access ends when you successfully complete the final examination. If you need more time, extensions are available upon request for a fee.
If a course manager purchases a seat without immediately enrolling the learner, the manager has up to 12 months from purchase to assign it.
This course is for people who need a working overview of ISO 13485 but are not responsible for implementing or auditing the entire QMS.
It is particularly suitable for employees joining medical-device organizations, professionals whose work is affected by the QMS, managers and process owners who need the big picture, and those considering more specialized ISO 13485 training.
After passing the final examination, you receive a digital ISO 13485 Foundation Certificate of Attainment. You can download it, print it, and add it to your LinkedIn profile.
Unlimited examination retakes are included at no additional charge.
There are no formal prerequisites. No prior knowledge of ISO 13485, quality management systems, or medical-device regulations is required.
Foundation Training is not a prerequisite for our role-specific courses. Learners who will implement or audit a QMS can go directly to the training for that role.
Yes. You can evaluate the complete course under our 30-day money-back guarantee.
If it is not right for you, request a full refund within 30 days, provided you have not completed the course.
Yes. Select the number of learners on this page and volume discounts are applied automatically.
A course manager can assign seats, enroll learners, and track progress from one dashboard.
The designated course manager can see each learner's enrollment status, course progress, and certificate status from one dashboard.
If a learner is not enrolled at purchase, the manager has up to 12 months to assign the seat.
The charts below show our approval ratings based on post-course surveys from 2000+ learners. Enroll risk-free with our 30-Day Money-Back Guarantee.
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