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.

  • 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
    • 44 hours / 4.4 CEUs
    • English
    • Exemplar Global Certified
    Learn more Enroll Now $1995

  • 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
    Learn More Enroll Now $1595

  • 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
    Learn More Enroll Now $1095

  • 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
    Learn More Enroll Now $695

  • ISO 13485 Lead Auditor / U.S. FDA CFR Part 820 QMSR

    This bundle includes two courses: ISO 13485 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
    Learn More Enroll Now $1895

  • ISO 13485 Internal Auditor / U.S. FDA 21 CFR Part 820 QMSR

    This bundle includes two courses: ISO 13485 Internal Auditor and U.S. FDA 21 CFR Part 820 QMSR 2026 Requirements.

    • On Demand / Student-Paced
    • 26 hours / 2.6 CEUs
    • English
    • Exemplar Global Certified
    Learn More Enroll Now $1495

  • U.S. FDA 21 CFR Part 820 QSMR 2026 Requirements

    NEW COURSE! This ON DEMAND 2-hour e-course teaches Quality Management System Regulations (QMSR) required by the FDA for Medical Devices and includes a certified training Certificate of Competence. This course details all of the new 21 CFR 820 regulations that are effective February 2, 2026. Includes the Top-10 FDA Inspection 483 Observations.

    • On Demand / Student-Paced
    • 2 hours / 0.2 CEUs
    • English
    • Exemplar Global Certified
    Learn more Enroll Now $695

Top 10 FDA Inspection Observations for Medical Devices