Our Exemplar Global accredited ISO 13485:2016 online courses are designed for professionals working in the medical device industry – from quality managers and implementers to auditors and regulatory specialists.
Whether you're implementing a QMS for medical devices, preparing for regulatory audits, or advancing your career, our practical, self-paced training delivers the specialized skills and internationally recognized credentials you need.
(188)
USD 795.00
Created by industry professionals and certified by Exemplar Global, this 40-hour course includes everything you need to become a Certified Lead Auditor and set up an audit program at your organization. As well as auditing techniques and audit reporting, tuition includes a solid overview of ISO 13485 and its requirements, documentation, implementation, best practices and practical tips.
40 hours (on demand)
Certificate of Completion
Exemplar Global certified
(268)
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.
16 hours (on demand)
Certificate of Completion
Exemplar Global certified
(92)
USD 545.00
Certified by Exemplar Global, this is an intensive, 24-hour course that details the ISO 13485:2016 standard, its benefits and requirements, and teaches the steps necessary to implement a Quality Management System for Medical Devices and achieve certification.
24 hours (on demand)
Certificate of Completion
(174)
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.
4 hours (on demand)
Certificate of Completion
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Earning your professional certification in ISO 13485:2016 validates your expertise and advances your career in the medical device industry, potentially leading to roles like Certified ISO 13485 Lead Auditor or Regulatory Affairs Specialist.
On successful completion of our Exemplar Global accredited training, you receive a prestigious Certificate of Attainment bearing the Exemplar Global mark – widely recognized by employers and certification bodies worldwide.
All certificates and badges are issued digitally and can be added to your LinkedIn profile for maximum professional visibility.
StandardsCourses is an Exemplar Global Certified Training Provider and Examiner (TPECS).
No. While the standard is focused on medical devices, our courses are also relevant for suppliers, distributors, importers, and service providers in the medical device supply chain.
ISO 13485 is more prescriptive and includes additional requirements for regulatory compliance, risk management, and traceability that are specific to medical devices. ISO 9001 is a general quality standard.
The ISO 13485 Implementer or Lead Auditor course is usually the best choice. Both cover regulatory requirements in depth and are highly valued by companies seeking compliance with FDA 21 CFR Part 820 and EU MDR.
Yes. Risk management is a core requirement of ISO 13485. Our Implementer and Auditor courses cover risk-based thinking and the application of ISO 14971 in detail.
Our Auditor, Lead Auditor, and Implementer courses are accredited by Exemplar Global. The certificates carry the Exemplar Global mark, which is widely recognized by regulators and certification bodies worldwide.
Yes — all courses come with a 30-day money-back guarantee. If you're not satisfied and haven't completed the course, you can request a full refund.
Becoming proficient in ISO 13485 directly supports several UN Sustainable Development Goals by ensuring the safety, quality, and reliability of medical devices used worldwide.
Goal 3: Good Health and Well-Being – The core purpose of ISO 13485 is to protect patient safety by ensuring medical devices are designed, manufactured, and monitored to the highest standards.
Goal 9: Industry, Innovation and Infrastructure – A robust QMS for medical devices drives innovation, improves product reliability, and supports resilient healthcare infrastructure.
Goal 10: Reduced Inequalities – High-quality, globally recognized standards help ensure safe medical devices are available more equitably across developed and developing countries.
