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 ISO 13485 Certified Quality Manager Medical Devices training program includes three courses: ISO 13485:2016 Lead Auditor, ISO 14971:2019 Medical Device Risk Management Requirements, and FDA 21 CFR 820 cGMP Requirements.

    • On Demand / Student-Paced
    • 44 hours / 4.4 CEUs
    • English
    • Exemplar Global Certified
  • 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
  • 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
  • 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
    • Certified Training