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 two-course professional program provides practical instruction in ISO 14971:2019 medical device risk management requirements and Failure Mode and Effects Analysis (FMEA) methods for identifying, evaluating, and reducing product risks.

Designed for medical device quality, regulatory, engineering, manufacturing, and risk-management professionals responsible for product safety and life cycle risk-management activities.

What This Program Helps You Do

Interpret ISO 14971:2019 requirements and apply them throughout the medical device life cycle.
Plan and document risk-management activities, including risk analysis, evaluation, control, and post-production monitoring.
Use FMEA to identify failure modes, assess their effects and causes, and prioritize risk-reduction actions.
Connect FMEA results to ISO 14971 risk-management documentation and ongoing risk-based decisions.

Courses Included

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ISO 14971:2019 Requirements

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: English.

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Failure Mode and Effects Analysis (FMEA)

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: English.

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Certificate Issue - ISO 14971 Certified Risk Manager - Medical

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 14971 Certified Risk Manager – Medical Devices.

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Enroll Now — $995 USD
Program Highlights
  • 2 Quality-Assured Courses
  • On-Demand and Self-Paced
  • 10 Training Hours
  • 1.0 CEUs
  • Language: English
  • 3 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 14971 Certified Risk Manager

Clear and Focused Training

Excellent training courses, with materials that are clear, simple, and to the point.

Kimlinh Harris

5 out of 5

ISO 14971 Certified Risk Manager

Simple Review and Easy to Understand

The material was simple to review and understand.

Bernard Warchuck

4 out of 5

ISO 14971 Certified Risk Manager

Met Expectations

This online training met expectations and allowed me to review the requirements of the standard efficiently.

Paul Meixner

5 out of 5

ISO 14971 Risk Management - Medical Devices Requirements

Extensive Information and Valuable Quizzes

Extensive information was provided, with valuable questions in the quizzes.

Deborah S. Ball

5 out of 5

ISO 14971 Risk Management - Medical Devices Requirements

Excellent Training and Customer Service

Velocity 360 provides excellent training and exceptional customer service. I will continue taking training through them and highly recommend the company.

Stephanie Blanco

5 out of 5

Failure Mode and Effects Analysis (FMEA)

Current Seven-Step FMEA Approach

I was pleased that the material covers the new seven-step approach and replaces RPN with the action priority assessment. I plan to study it further.

Fred Lane

5 out of 5

ISO 14971 Risk Management - Medical Devices Requirements

Informative and Easy to Use

The course was very informative and easy to use.

Steven Stone

ISO 14971 Certified Risk Manager – Medical Devices Certificate

Earn Three Secure, Digitally Verifiable Certificates

Complete the program to earn the ISO 14971 Certified Risk Manager – Medical Devices certificate and two individual course certificates, which can be added to your professional profile.
Enroll Now — $995 USD