WHY TRAIN WITH VELOCITY 360?

Certified Provider.
Quality-Assured Training.

Velocity 360 training products are developed within our ISO 9001:2015 quality management system, certified by NQA, an ANAB-accredited certification body. We are also an Exemplar Global Certified Training Provider for select training programs.

Exemplar Global, NQA ISO 9001 and ANAB accreditation credentials

Program Overview

This four-course program develops practical competencies for leading ISO 13485:2016 medical device quality management system audits, applying ISO 14971:2019 risk management requirements, strengthening documentation and data integrity, and using FMEA to control product and process risks.

Designed for medical device quality managers, lead auditors, regulatory professionals, engineers, manufacturing personnel, and compliance professionals responsible for quality systems, risk management, and regulatory readiness.

What This Program Helps You Do

Interpret ISO 13485:2016 requirements and lead medical device quality management system audits using ISO 19011:2026 guidance.
Apply ISO 14971:2019 requirements to identify, evaluate, control, and monitor medical device risks.
Strengthen documentation and data integrity using Good Documentation Practice and ALCOA+ principles.
Use FMEA to identify, assess, and reduce medical device product and process risks.

Courses Included

ISO 13485:2016 Lead Auditor [Spanish]

This On-Demand, 32-hour e-course provides practical instruction in ISO 13485:2016 medical device QMS requirements and ISO 19011:2026 guidance for conducting and leading audits. Includes a Certificate of Competence. 3.2 CEUs. Language: Spanish.

ISO 14971:2019 Requirements [Spanish]

This On-Demand, 6-hour e-course provides practical instruction in the concepts, requirements, and best practices of ISO 14971:2019 medical device risk management. Includes a Certificate of Competence. 0.6 CEUs. Language: Spanish.

Good Documentation Practice and Data Integrity [Spanish]

This On-Demand, 4-hour e-course provides practical instruction in Good Documentation Practice and the ALCOA+ principles of data integrity. Includes a Certificate of Competence. 0.4 CEUs. Language: Spanish.

Failure Mode and Effects Analysis (FMEA) [Spanish]

This On-Demand, 4-hour e-course provides practical instruction in the seven-step FMEA methodology, risk analysis, rating criteria, Action Priority, and auditing FMEA effectiveness. Includes a Certificate of Competence. 0.4 CEUs. Language: Spanish.

Certificate Issue - ISO 13485 Certified Quality Manager - Medical Devices [Spanish]

This final certificate-issuance step follows successful completion of all prerequisite courses and program requirements. Completing the step issues a Certificate of Competence for ISO 13485 Certified Quality Manager – Medical Devices.

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Program Highlights
  • 4 Quality-Assured Courses
  • On-Demand and Self-Paced
  • 46 Training Hours
  • 4.6 CEUs
  • Language: Spanish
  • 5 Certificates of Competence
Enrollment Benefits:
  • Immediate access after enrollment
  • 12 months of unlimited access—even after completion
  • Certificates issued immediately upon completion
  • No added exam or certificate fees

What Learners Say

Feedback from professionals who completed Velocity 360 training.

5 out of 5

ISO 13485 Certified Quality Manager - Medical Devices

Comprehensive Quality Manager Training

A valuable compilation covering FMEA, ALCOA+, ISO 13485 auditing, and ISO 14971 risk management requirements. It refreshed and updated my knowledge and has helped me become a better auditor.

Ricardo Franco

5 out of 5

ISO 13485 Certified Quality Manager - Medical Devices

Excellent Training and Customer Service

Velocity 360 provides excellent online training. Customer service answered all my questions, and I highly recommend it to anyone interested in earning a certification.

Stephanie Blanco

5 out of 5

ISO 13485 Certified Quality Manager - Medical Devices

Clear and Helpful Course Content

The course text was good, and the additional comments were helpful.

Erica Cheetham

5 out of 5

ISO 13485 Lead Auditor

Comprehensive Course

An awesome and comprehensive course.

Harvey Manley

5 out of 5

ISO 13485 Lead Auditor

Great Lead Auditor Training

Great training.

Ashutosh Singh

5 out of 5

ISO 13485 Lead Auditor

Excellent and Thorough Program

Excellent program. Very thorough.

David Prosser

ISO 13485 Certified Quality Manager – Medical Devices Certificate

Earn Five Secure, Digitally Verifiable Certificates

Complete the program to earn the ISO 13485 Certified Quality Manager – Medical Devices certificate and four individual course certificates, which can be added to your professional profile.