Medical Devices
Exemplar Global Certified Training
Certified Quality Manager - Medical Devices
The Certified Quality Manager Medical Devices is a 44-hour 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. 4.4 CEUs. Language: English.
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.
ISO 13485:2016 Lead Auditor Certification
This 32-hour e-course teaches a detailed understanding of the concepts and requirements of the ISO 13485 Medical Quality Management standard and ISO 19011 Lead Auditing and includes a certified training Certificate of Competence. Exemplar Global Certified. 3.2 CEUs. Language: English.
ISO 13485 Internal Auditor / U.S. FDA 21 CFR Part 820 QMSR
ISO 13485:2016 Internal Auditor Certification
This 24-hour e-course teaches a detailed understanding of the concepts and requirements of the ISO 13485 Medical Quality standard and ISO 19011 Auditing and includes a certified training Certificate of Competence. Exemplar Global Certified. 2.4 CEUs. Language: English.
ISO 13485:2016 Requirements
This 16-hour e-course teaches a detailed understanding of the concepts and requirements of the ISO 13485 Medical Device Quality Management standard and includes a certified training Certificate of Competence. 1.6 CEUs. Language: English.
U.S. FDA 21 CFR Part 820 QMSR 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. 0.2 CEUs. Language: English.
ISO 13485:2016 Overview
This 1-hour e-course teaches a very brief overview of key concepts and major requirements of the ISO 13485 Medical Device Quality Management standard and includes a certified training Certificate of Competence. 0.1 CEUs. Language: English.
FDA 21 CFR Part 11 Electronic Signatures Requirements
This 1-hour e-course teaches a brief overview of the key concepts and major requirements of the FDA 21 CFR Part 11 Electronic Records and Signatures and includes certified training Certificate of Competence. 0.1 CEUs. Language: English.