ISO 13485 - Certified Quality Manager Medical Devices [Engli

ISO 13485 Certified Manager

The ISO 13485 Certified Quality Manager Medical Devices is a 46-hour training program for four on demand e-courses. ISO 13485:2016 Lead Auditor (Exemplar Global Certified), ISO 14971:2019 Medical Device Risk Management Requirements, and FDA 21 CFR 820 cGMP Requirements, and Good Documentation Practice. 4.6 CEUs. Language: English.

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Courses Included

ISO 13485:2016 Lead Auditor [English] Exemplar Global Certified-25

This ON DEMAND 32-hour e-course teaches an understanding of the requirements of the ISO 13485 Medical Quality Management standard and ISO 19011 Lead Auditing and includes a certified training Certificate of Competence. 3.2 CEUs. Language: English.

$1,595
ISO 14971:2019 Risk Management Medical Devices Requirements [English] Exemplar Global Certified-25

This ON DEMAND 6-hour e-course teaches a detailed understanding of the concepts and best practices of the ISO 14971:2019 Medical Device Risk Management standard and includes a certified training Certificate of Competence. 0.6 CEUs. Language: English.

$695
FDA 21 CFR 820 cGMP Requirements [English]-25

5.0

This ON DEMAND 6-hour e-course teaches 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. Language: English.

$695
Good Documentation Practice and Data Integrity-ALCOA [English]-25

This ON DEMAND 2-hour e-course teaches a brief overview of the key concepts and major requirements for ISO Good Documentation Practice and Data Integrity-ALCOA and includes certified training Certificate of Competence. 0.2 CEUs. Language: English.

$295
Certificate Issue - ISO 13485 Certified Quality Manager - Medical Devices-25

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 GDP. 4.6 CEUs.

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Our certificates are secure, digitally issued, and verifiable online by any third-party, registrar, or certification body. You can easily add your credential to your LinkedIn or other social media profile.

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Get Certified for each Course Included

Additionally, you will receive certification Certificates of Competence for each course in the training program, including: ISO 13485:2016 Lead Auditor (Exemplar Global Certified), ISO 14971:2019 Medical Device Risk Management Requirements, and FDA 21 CFR 820 cGMP Requirements and Good Documentation Practice.