Medical Devices
Exemplar Global Certified Training
Certified Quality Manager - Medical Devices
The ISO 13485 Certified Quality Manager Medical Devices training program includes 4 courses; ISO 13485:2016 Lead Auditor, ISO 14971:2019 Medical Device Risk Management Requirements, FDA 21 CFR 820 cGMP Requirements, and Good Documetnation Practice.
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 13485:2016 - Onboarding
The ISO 13485 Onboarding training bundle begins the process of integrating a new employee with essential quality system requirements. This bundle includes courses on ISO 13485 Requirements, Risk Management, Culture of Quality, Good Documentation Practice, Trade Secrets, and others. A Certificate of Competence is issued for each course. Language: English.
ISO 13485:2016 - Training Bundle
The ISO 13485 training bundle includes three ON DEMAND e-courses, including ISO 13485 Internal Auditor (Exemplar Global Certified), ISO 14971 Risk Management Medical Devices Requirements, and Failure Mode and Effects Analysis (FMEA). Language: English.
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.
FDA 21 CFR 820 cGMP Requirements
This 6-hour e-course teaches the Quality System Regulations (QSR) and Current Good Manufacturing Practices (cGMP) required by the FDA for Medical Devices and includes a certified training Certificate of Competence. 0.6 CEUs.
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 820 cGMP - Overview
This 1-hour e-course is an annual GMP Overview of the Quality System Regulations (QSR) and FDA 21 CFR 820 GMP requirements for Medical Devices. Includes a certified training Certificate of Competence. 0.1 CEUs.
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.