Our ISO 13485:2016 curriculum provides four levels of practical online training for medical-device professionals – from a clear foundation in the standard to implementation, internal auditing, and leading audit programs.
All four courses are self-paced and include an online assessment with unlimited retakes and a Certificate of Attainment. Certificates for Auditor and Lead Auditor Training also carry the Exemplar Global logo.
(208)
USD 795.00
Lead complete ISO 13485 audits of medical device QMSs. Evaluate regulatory and quality controls, direct audit teams, report findings, and manage audit programs. The certificate bears the Exemplar Global logo and supports application for relevant Exemplar Global personnel certification.
40 hours (self-paced)
Certificate of Attainment
Exemplar Global logo
(298)
USD 495.00
Conduct assigned ISO 13485 internal audit activities and evaluate whether a medical device QMS meets standard and regulatory requirements. Learn practical evidence-gathering, reporting, and corrective-action techniques. The certificate bears the Exemplar Global logo and supports application for relevant Exemplar Global personnel certification.
16 hours (self-paced)
Certificate of Attainment
Exemplar Global logo
(102)
USD 545.00
Build a practical ISO 13485 QMS for a medical device organization. Translate standard and regulatory requirements into controlled processes, effective documentation, and certification readiness.
24 hours (self-paced)
Certificate of Attainment
(194)
USD 125.00
Understand how ISO 13485 supports consistent quality and regulatory compliance in medical device organizations. Connect its requirements, process controls, documentation, risk-based thinking, and certification without specialist implementation or audit detail.
4 hours (self-paced)
Certificate of Attainment
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After successfully completing your course and final assessment, you receive a digital Certificate of Attainment documenting your ISO 13485 training. Every certificate bears the IACET accreditation mark.
Certificates for our Auditor and Lead Auditor courses also bear the Exemplar Global logo and provide a pathway toward relevant Exemplar Global personnel certification.
Certificates are issued digitally so they can be saved, shared with employers or clients, and added to your LinkedIn profile.
91%
91% of HR Managers believe Professional Credentials are valuable for employee development.
88%
88% of job seekers find their Digital Credential helpful in achieving their career goals.
93%
93% of US organizations do at least some of their compliance training online.
Foundation Training is the best starting point for newcomers. It provides a four-hour introduction to ISO 13485 requirements, documentation and certification without the depth of the role-specific professional courses.
Choose Implementer Training if you will develop, document, implement or maintain the medical-device Quality Management System.
It provides more implementation depth, practical guidance and sample documents than Foundation Training.
Auditor Training prepares learners to conduct internal audits and participate as effective audit-team members.
Lead Auditor Training adds the skills needed to plan and lead audits, manage audit teams and oversee an audit program.
No. ISO 13485 applies throughout the medical-device supply chain.
The training is relevant to manufacturers as well as suppliers, distributors, importers, service providers, quality professionals and regulatory specialists.
ISO 13485 is specifically designed for medical-device Quality Management Systems. It places greater emphasis on regulatory requirements, risk management, traceability and controlled processes. ISO 9001 is a general quality-management standard that applies across industries.
Yes. Risk management is fundamental to ISO 13485 and is addressed throughout the curriculum.
The professional courses examine risk-based approaches in greater depth, including the role of ISO 14971 in medical-device quality management.
The Auditor and Lead Auditor courses award a Certificate of Attainment bearing the Exemplar Global logo after successful completion of the course and assessment.
Both provide a pathway toward relevant Exemplar Global personnel certification. Certificates for all four courses bear the IACET accreditation mark.
Yes. All courses come with a 30-day money-back guarantee. If you are not satisfied and have not completed the course, you can request a full refund with no questions asked.
Learners receive up to three months of course access from enrollment. Access ends when the course is successfully completed. Extensions are available upon request for an additional fee.
If the buyer does not enroll the learner during purchase, the course manager has up to 12 months to enroll them.
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.
