ISO 13485
Exemplar Global Certified Training
ISO 13485 Courses
ISO 13485 is an international standard that defines the requirements for a quality management system (QMS) specifically for the medical device industry. This comprehensive standard covers all aspects of the product lifecycle, from design and development to production, distribution, and post-market surveillance.
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ISO 13485 Certified Quality Manager - Medical Devices
The Certified Quality Manager Medical Devices is a training program for 5 e-courses: ISO 13485:2016 Lead Auditor, ISO 14971:2019 Medical Device Risk Management, FDA 21 QMSR 820 cGMP Requirements, GDP and FMEA.
- On Demand / Student-Paced
- 42 hours / 4.2 CEUs
- English
- Exemplar Global Certified
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ISO 13485 Lead Auditor Certification
This course teaches a detailed understanding of the concepts and requirements of the ISO 13485:2016 Medical Quality Management standard and ISO 19011:2018 Lead Auditing of Management System.
- On Demand / Student-Paced
- 32 hours / 3.2 CEUs
- English
- Exemplar Global Certified
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ISO 13485 Internal Auditor Certification
This course teaches a detailed understanding of the concepts and requirements of the ISO 13485:2016 Medical Quality standard and ISO 19011:2018 Internal Auditing of Management System.
- On Demand / Student-Paced
- 24 hours / 2.4 CEUs
- English
- Exemplar Global Certified
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ISO 13485 Requirements Certification
This course teaches a detailed understanding of the concepts and requirements of the ISO 13485:2016 Medical Device Quality Management standard.
- On Demand / Student Paced
- 16 hours / 1.6 CEUs
- English
- Exemplar Global Certified
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ISO 13485 Lead Auditor / U.S. FDA CFR Part 820 QMSR
This bundle includes two courses: ISO 13485:2016 Lead Auditor and U.S. FDA 21 CFR Part 820 QMSR 2026 Requirements.
- On Demand / Student-Paced
- 34 hours / 3.4 CEUs
- English
- Exemplar Global Certified
