ISO 13485:2016 Complete Training Track (3 Courses, 3 Certificates)
ISO 13485:2016 Complete Training Track (3 Courses, 3 Certificates)
Online course. Unlimited access. Certificate of completion.
Couldn't load pickup availability
- Unlimited access. No expiry. Study at your own pace and come back any time.
- About 46 hours of learning. Self-paced online course with short lessons, a worked case study, downloadable worksheets and model answers.
- Every lesson quiz must be passed at 100% before the lesson counts as complete, with unlimited retries. You finish knowing the material, not just having clicked through it.
- Certificate of completion issued when you pass the final exam.
- Access starts straight after payment. Log in with the email you used at checkout and open My courses.
Certificates are certificates of completion issued by ISO Cloud Consulting. We are a new training provider and our certificates are not yet accredited by an external body. We plan to apply for international recognition of our certificates before the end of 2027.
Already enrolled? Go to My courses
All three ISO 13485:2016 courses in one purchase: Foundations, Internal Auditor and Lead Implementer. About 18 hours of video and about 46 learning hours of medical device quality management training, with a Certificate of Completion for each course. Bought separately they cost $797; this ISO 13485 training bundle saves you 25%.
- Format: three online, self-paced courses, any device
- Access: unlimited access to all three courses, granted the moment your order is paid
- Assessment: knowledge checks after every lesson (100% to continue), module quizzes and an open-book final exam per course
- Certificates: three Certificates of Completion, one per course
What you get
- ISO 13485:2016 Foundations: every clause in plain English, the vocabulary, the roles, and how 13485 differs from 9001.
- ISO 13485:2016 Internal Auditor: the audit cycle, clause 8.2.4, special processes, role-plays, a full mock audit of a catheter manufacturer with evidence pack and templates.
- ISO 13485:2016 Lead Implementer: the 30-week implementation roadmap, every required procedure and record, the medical device file and design file in practice, post-market design and the certification journey.
Suggested order
Foundations, then Internal Auditor, then Lead Implementer. Experienced quality professionals can start with Internal Auditor.
Who it is for
Quality and regulatory professionals, consultants and founders who need full command of ISO 13485:2016, engineers moving into medical device quality, and device companies training a quality lead.
About your certificates
Each course ends with an ISO Cloud Consulting Certificate of Completion. These are certificates of completion only: they are not accredited or certified qualifications and they do not certify any organisation. ISO Cloud Consulting is a new company and intends to apply for international recognition of its course certificates before the end of 2027. Today they serve as documented evidence of training under ISO 13485:2016 clause 6.2.
Frequently asked questions
Which ISO 13485 course should I take?
New to medical device quality: Foundations. Auditing your own or a supplier's QMS: Internal Auditor. Building or upgrading a QMS: Lead Implementer. The bundle covers all three in order.
Is ISO 13485 training worth it for a career change?
Medical device companies need people who understand ISO 13485, design controls, risk management and post-market requirements. Documented training plus a portfolio of worksheets and a capstone gives you concrete evidence to show employers.
How long do I have access?
Unlimited access to every course in the bundle, with no expiry date.
Lessons are narrated with a natural-sounding AI voice from scripts written by the instructor; slides are included as downloads. You need your own licensed copy of ISO 13485:2016. 5-day fit guarantee, before taking any final exam. Course author: Ishan Maharaj, ISO Cloud Consulting.
Course questions
How long do I have access?
Unlimited access. No expiry date. Study at your own pace and come back to any lesson whenever you need it.
Is the certificate accredited?
You receive a certificate of completion from ISO Cloud Consulting when you pass the final exam. We are a new training provider and our certificates are not yet accredited by an external body. We plan to apply for international recognition before the end of 2027.
How do I get into the course after I pay?
Access is granted automatically once payment is confirmed. Log in with the email you used at checkout and open My courses. You also receive a welcome email with the link.
Why must I score 100% on lesson quizzes?
Each lesson ends with a short knowledge check. You need every answer right to complete the lesson, with as many retries as you need. Your certificate then reflects real understanding.
Can my team take the course?
Each purchase enrols one learner. For team pricing, contact us.